LL . Mum-"Division of Health Pmf?ssitms Licensure INVESTIGATION REPORT . Page 1.of 10 - flicensee Name: 1 - Docket Non . New?ngland Campounding Cente . ''95 03 055. Arid. -, . - Barry Cadden_ PH 03 Q66 Fri-ori.ty Code: 2 -Received by DHPL: 2/12/2003 Docket; Op?ned; - 2/12/05 . .. Assigned: . . 2/1_2/033 Inve?tigat?r Nafngz Leslie 8. Doyle, Supervigor Pqntikas.=Director . I - I as I: Demographics and'H'istory . A. Licensee' Information 1.. Nanie of Bany Cadden 2. Address of Record: - 3. Phone' - - Busine?s: (508) 320 0505 Home: - 4.: Lieensee[Re?pondent iliate of Birthi . - Licenseffpe 8L PH E11239 I . Curretnt Status: . Exp. Date: 12/31/94 6. lii?cifilihe (?ncpf?in): I I - I. '_Both phar:mar:ist and pharmacy have prior - thge specifics are stated be!ow._ .7. I Origfina] Date of Issuance: England Compounding Center issued 2116/ 1998 D5 2848 PH - Barry Cadden - Manager of record issugd 10/9/1990 PH 21239 Record of Standing eittacheqnot, ftem 9 below: 9. Name of Institution Attenciedi . University of Rhode Island Date of Graduation: MDPH-Divisi'on'of Health Peei?ession? Licensure INVESTIGATION REPORT Page' 1 of 10 Licensee Name: Docket No! 'New England Co;npoundiIig' Center DS 03 955 And . Barry Cedden PH 03 066 . Prioritiricode: 2. Received by DHPL: 2/12/-2003 I Docket Opened: 2/12/03 . . Assigned: 2/12/03 -Inveetigatar Name: Leslie 3. Doyle, Compiiance Officer -. . L?upewfsor Nan'1e':- Directzer re' . I - ane History - . A. licensee Informatiog Name of Licensee/Respoedent: Barry Cadden . fiiddfess of i1ecerd:' A. 3. Phone Home: - Cell: Business: I .4. Licensee] Respondent 5. a License Type 8: No.: PH 21239 Current Status: . Exp. Date: 12/31/04 6. Prior Discipline (explain): 'Both 'phanfiak:i's't and prior? Complaint history. 1-. the sgleecifics are stated below. I Original Date of Iesuence: as England Compounding Center iesued'7/16/1998 DS 2848 PH Barry Cadden - Manager of record lssyed 10/9/1990 PH 21239 8. Recordef Standing atteched: Yes_ 1. No If not, cemplete item 9 below: .9. . Name of Educational -In'stitufion-Attended: University oi' Rhode Island Date of Graduation: 1990 c. Non-MAss5'cHusErrs . . MDPH-Divisioh of Heelfh Profes?lons Llcenoure mvesrronnon REPORT . Page 2 of 10 Licensee' Nanie: Dpckel: No.' New England Compounding Center D5 03055 And - Barnfcadden PH 066 B. OTHER LICENSES HELD: El. . Professionflrade: NA 2. License No. Current: Status: Exp. Dare: 2' 53, Prior-gpiscipline (eXplain):_ - a. Certified Documentation Attached -- I:l,Yes 2-(No 1. Profession I Trade: Phannaoy licenses are held In. all out four states throughout the United States. Current Status: Exp. Date: 2.. License No. . 3. error (explain): 4. Certified Dooumentatlon Attached [Wes No o. . 1. Current Employer: Center . Address: -697 Waverly 01702 . 3. 'Telepl1or_le_ Numloer: (508) COMPLAINT Hrsronv: 'Companion Cornplaints: (list docket numbere, allegations, fstatus, and olsposlfion) Qrug Store Prlor History and 'outcome: -20,021211ds036 -- Board complaint - allegafions: unprofessional conduct (JCE) pending board decision -- 2/_2s/03 20032026ds06.0 - Consumer complaint -- (Marsh) 'allegations: failure to adhere to standards of practice pending board decision 4/ 1/ - -7 . 4 I A Board complaint -- allegations: unprofessional condu MDPH-Division of.Health_ Professions Lioensulte INVESTIGATION REPORT -- -Page 3 of 10 Licensee Name: Docket" No. New England Compounding Center 5 as 03' ass . And B_arry Cadden PH 03 065 Pharmacist Cadden Qfior ahd'outcog1e: 19990330phO66-- Board comolainti allegations: violation of CMR 247 sec-:tioh' 9.01(3) (JDC). Infonnal Reprirnand issued for supplying to practitioners, dismissed 12/ 1/0/-'(JCE) pending board decision, - . iDD30226pnb70 -- Consumer complaint - (Marsb) allegations: failure to adhere to standards of practice - (JCE) pending board decision, . - Pending/Related Complaints: (list docket nurnbers, allegations, siatus,and disposition) See above as -stated - Criminal Offender Records Information Check (CORI) been perfornuedif El Yes No Include certified copies ofjudgments - -- . A .-- SECTION ii: ginteruieuys, Complainant Info Index of 3.. INTERVIEWS CONDUCTED: List below and include labeled interview notes in case-file Contact Informeifion Individuals Interyievlred -jwhen/Where? Type Jinterview (name/title) - (dates/time of (in-person/phone) (phone, address, 'day) - . businessNOT INTERVIEW: Document attempts in case file Contact Information to contact Individuals . (phone, address, business) (dates, times) - 2. 3. Health liirotessions Licensure INVESTIGATION naponjr - Page 4 of '10 'Licensee-Name: l. 'u T. Docket No., I New England Compounding Center b8 03' 055 - 'Barry Cadden PH 93 D66 c. INFOBMATION: Ii; NAME OF COMPLAINANTT . I Mass. Board of Registration in Pharmacy' - .-- - 239 Causeway 51%. Suite.-500 - Boston, MA .., cf PHONE 727 9953 can. Pnone: n/a) more': or MA1jsniAts'/Documents: Label documents/materials as noted belovy in order I of presentation in the file ITEM A: Complaint - ITEM Record of -standing - trenrc: Complaint history -ITEM List of Concerns. ZETEM NECC response to allegations ITEM Air 'Analysis ITEM gs: Procedures . ITEM H: NECC response . I: FDA .Letter to Board ITEM 3: Copy of 2/20/2094 Compliance lnsgection. - Investigation Summary A. gmecration of Complaint: give nature codeand sunimarize t_he.allegations: Complaints as referenced in docket numbers DS 03-055 and PH 03 066 were filed by the Mass; Board of Registration against New England Compounding Center, and Barry Cadden, Manager of record for the on' to ad_bere_ to standards of compounding', Specifically, the pharmacy. and pharmacist engaged in - unprofessional conduct as 'exhibited by; failing to fdllow guidelines, sterility procedures, record keeping batch records, failing to provide certificates of analysis, proof of sterility testing; Endotoxintest results, batch numbers and prescriptions upon request. . 'v A S-etti Where Alle ed nci'dent_ Conclucl:'0ccurred:- 1. Facility or Business Type: Pharmacy Pharmacy Name: . New England Compounding Center Address: 697 Waverly St. Frarningham, Ma 01702 Phone No: 508 820 '0696 - . Contact Person: - Barry Cadden Contact's Title: - Manager of Record . . . .. . .. - -, ., -. -.-..- . . .53.. 55MDPH-Division of Health Professions Licensure REPORT Page -5 of 10 Licensee Name: Docket No. New England Compounding Center 03' 066 "Barry Cadden' Lioenseeis Supervisor (if applicable give name): not applicable -Phone No: - A I C. 'Attorney; of Record - 1. Name of Attorney: Attorney John Tamkin 3~ Attorney Jeff Gibbs . 4' 5 -. -- .- Attorney Paul-Cirel - ,617.371 1025 Hyman, Phelps, McNamara 202 737 5600 For concerns: . . . 'Attorney Douglas'B Farquhar 202 737 5600 2. Name of Firm: 3. Address: . - Rhone - - D. Answerof Respondent (summarize licensee's responseto allegations): . litiensee denied _the,allegations a_nd__has submitted copies of policy and procedures along corrective measures. - . E. 3 Investigatoris Activities and Findings': - - - - Describe in narrative format_~ who, _what, where, when, an_d_why and include-citations to laws and regulations when applicable to the case-. - The Mass. Board of Registration in Pharmacy has filed a complaint against New England Center (NECC) and Ba ray Cadden, Manager of record, as it relates to the standards and procedures,.sterility, record keeping, certificates of analysis, stenlity' testing, Endotoxin test results, compound fonnuladons, and_batch__ reco'rds'for_ product as riotbe produced and 'matched up to dispensed Based on a confidential report submitted on a Med. Watch form to the District bffice of.i:he Food and Drug (FDED in Stoneham, it is alleged that NECC compounded Betan1ethasone.Repository Injection pursuant to patient specific prescriptions, and delivery to an unnamed medical facility where the rnedicatioh was administered to It is alleged that the patient(s) had an adverse event after the administration of this compounded drug. In both instances the drug was prepared by New England Compounding Center. . . . During the compounding and preparation process at NECC lot numbers were assigned to the product. Mr. - Cadden could not produce an of the product compounded. The FDA was concerned regarding a specific date the Batch ofBetarnetl1asone Repository 6mg/ml was compounded. 'me error was first reported in . March 2002. "line unnamed facility conduiztecl sterility and Enclotoxin tests on the produ_ct'prepared_by NECC, the results indicated a positivetest for Endotoxin . - A - - 'Barry-Cadden - by FDA. Mr. Cadden stated while the lot number was -indicating training of staff was provided. Mr. Cadden also stated the medication was 'being "administered via the . certified and registered with the Center of America in Texas after six' month of employment In addition: . MDPH-Division of Healt,h'Professions Licensure REPORT Page 6 of IO Licensee Name: '.Docket No. . Nevv England Gompounding_Center- DS 03 055 . 'And . Ir ran as 066 - Mr. Cadden explained that' at the time of preparation, lot numbers were assigned to each patient, however, upon request to review such documentation Mr.' Cadden could. not provide records for the lot number identified generated, the medication was 'not dispensed. However, there was no notation to indicate such and, Further no prescriptive records could be provided, nor certific'ates'of analysis, Endotoxin test results, sterility test results, procedures on aseptic techniques or records a I When asked-to describe his compounding process forrthe Betamethasone Repository Injection Cadden stated he used _$oclium 'as ansuspending agent. After the suspending agent was added the product was placed in the IV hood located in the IV room to cool for-up to 4 hours. A sample is taken and sent to the test lab (Analytic Research Lab 840 Research Parkway, #546 Oklahoma City Oklahoma' 73104.) Testing may take up to seven days, and during this time the product remained in the-hood capped with foil. . - . _epid.orai route, a,non--approved routeot administration. In response to this incident,' NECC changed the suspending agent In February, 2003, Mr..Cadde_n responded to the allegations with corrective measures in February 2003 that he hired a consultant to develop' policy and procedures. Eric Brennan). All technicians are now Board of Pharmacy. All staff receives b'aining- from Phannacy Compounding stating" 1) All chemicals purchased are in date; beyond use dates are products are ordered from' FDA registered facilities. provides formulations for compounding. - - -Certificate of analysis for all chemicals-are now kept on site. Analytical tests resultsare obtained ar__1d_l_> Advisory Letter - stayed Probation term: Continuing -Eduoation _.Revoeation tern}: I Offer Voluntary Surrender Non-disciplinary Agreamant - Notasr . - .. Based on this pharmacfs 'history as it relates to priorconcems of the Board agents since 1999, Ms this investigatorfs a formal reprimand should be this time February 20,2004-a roinspection of the'pha'm1acy Indicated that the corrective measures are-In place and have been foilowad through as stated in Mr." Cadden's response to 3 the. Board. BOARDS Board Meeting Date: Dismissal Forrnal Reprfmand Dismissal wgtnogt farejuuide _CansL!re Dfs'mussa'l_with prajudioa I Summary? Suspension No Violation . suspension term! Lack of Sufflcieht Euidence 'Aclvisory getter Probation term: Continuing Education Stayed _Prcibation terns: . - Revocation term: Qffer Voluntary Surrender Nofas: . MDPH-Division of Health Pfofession? Licen?ixfe REPORT . . . - Licefisee N?me? Dcicket No.~ nzsposxnori OF CASE: Refer to Board Coun?sal Date: *3-"Refer to . - -Br. Other - The Cbm.monwealth of -Massachusetts Executive-Qffice of Healfh and Human Services Department of Public Health - - Board of Regisfrafion I Phannacy' . . . 239 Causeway Street, Floof - UEUTENANF GOVERNOR RQNALQ mesron SECRETARY COMMISSIONER Cctobe:f04,2Q04 . Barry I. Cadden, Manager 'of RE:c0i:d- New England Compounding Center 697 Walvexly Street Fraaninghafir, 01702 RB: Iiockef 1_\Tu111ber -06 6/ Nev}! England Co?r11poImdiJ1g Ceiufer (Lia. No. 2343) a:r;dBaJ:ry' Cadden, RPIL, License No. 21239 . Dear IVII. Cadden: - The Board has voted to resolve the above--refar?nced case by ?fiefipg you ai cbnsent'agreem?nt to resolve issues reylafed to the above--referenced matter. - Plea?e be advised that if 3.5011 choose dot to eptef into the Agreement, 'd1e Board will proceed to a formal healing, pursuant to GL. 0. -. 'Please rredmxn both copies to ths.Boa:rd at your earlie?t convenience but no laier -fhanwifthin-ten (10) days oftheif receipt. The Board-will the}; sign-them: and an executed-c0py~ - I will be returned to ypu. _P1ease pontact Asgsociate Dixectdy: Tamas D. Coffey at 617-727-6695 if you have any questions matter. . . . Sinmgrely, 633*- Cha_;r1es_R. Young, Execuiive Director Board of Registration InPhannac E110. - By C?rfified 1321351 7003 1010 0003 3509 7959 . . 250 Washington Street, Bostgn, MA 02108-4619" on MASSACHUSETTS . Boann os SUEHOIK COUNTY .- JNPHARMACY In the Matter of NEW ENGLAND . . . . COZMPOUNDINGCENIER 3 DOCKET NOS. ns~o3~o55 . '0 Regisb:ati0nNo- 2848- - - BARRY J. - License No. 21239 . . CONSENT AGREEMENT . CENFER (Phannacy Registration No. 2848), 10 eated at 697 Waverly Road, The Board of Registration in Pharmacjr i - in Framingham, Massachusetts ('Registtanf'), and BARRY CADDEN, 11191;. Pharmacist Lioenseifio. 21239 'and Manager-of Record of Registrant, do hereby stipulate and agree that the following infonnation shall be entered into. and become a permanent part of the file ofllegistvani Which ismaintained by-the Board: The fiarties eniei: 'Consent emf') to - out of the complaints pending against Registrant and Licensee, respecigivelyz as . DS--O3--O55 and PH-03-O56 - The Registiant that this Agreement has been entered into as a result of an adverse - . eireni complaint report investigated by the Us.' Food and Drug A on alleging that - Registrant, while the Licensee was Manager of Record, failed to comply with' accepted standards in compounding a certain order fof acetate preservative 80mg/m1'suspeasion - - Accordingly, the Registran1_E agrees to the following: The oonduct described in Paragraph 2. above constitutes professional misconduct . watraniing disciplinary aefion by the Board putsuantiao o. 112, 61 and 247 .. < gap-analysis and standards. .In'a?lditi on, NBCC has recently formalized 23. Assurance Team" which includes . - the director ofpharrnacy, the head technician, a'sterj1_e technician, the general manager and the rnarlceting manager. The Teapn gneets with the stated mission of . - ehrninating pharmacy eiror. Finally, following the suggestion :En'Mr. Young's letter (at: - paragraph NBCC has formalized an afietgbusnress hours protocol-to insure 24/7 Iiraisoaxa orsegiseaeon i11Phannacy I - February 20," 2004 . Ms. Leslle Doyle and Mr. James Emery la . . Septemher 23, 2004 A .- Mr. James Emery and MI. Leon Mclienna at-act M-A Board of Registration in Phannacy Iames Emery and Mr. Leon Molienne and - -- - - September 23, 2004 All of these inspections have been Without incident. While I think it an to- sayithat the product interaction with the Board -- as dernonstrated above is a success story, snchavould notbe the case if the resolution -- Staff, flcilifies, and I I .-.. Susan Manning, Esq. - 'November 11,2004 Page 3 letter). The collateral consequences to many, if not all of NBCC's 42 other licenses, would be potentially fatal to the busi11ess.Z Such a catastropheis clearly not the intended' . -result of the Board's proposed reprimand, nor is it warranted in this case. The Bo ardfs mandate is toprotect'. the public health safety and welfare, not to punish its licensees (gag V. Board of Public Accounfing 394 Mass. 118, 127-128 (1985); V. Board - Medicine 378 Mass. 519, 527 (1979). Mr. Cadden and NECC have demonstrated their commitment to renlediation, and are prepared to continue to do so. In that regard, and Cadden will agree to all of the probationary terms oered in Yo_ung's letter, and.W1'll.fi1rther agee to bear the burden and cost of monitofing and reporting their compliance} That result could be . . accomplished through a non-disciplinary resolution such as a continuance (pending a period ofnnonitoring) or a "stayed probation." Whatever the vehicle, Mr. Cadden and NBC are ready, willi_r1g and able to insure all of the public protection components :of Young's proposed resolution, but respectfiilly request that the Board do so Without also imposing discipline which may destroy their business.' Both Mr. -Cpadden andl are available to meet with you, Mr. Young and/or the Board itself-to discuss resolution of this roatter, We look forward to your reply. . . Very ., - - 2 Once disclosed, the reprimand will surely-result in inquiries/investigations in those other Regardless of the clerivattve taken, the attendant legal and administrative costs will be detfastatirig. ,3 NECC is prepared to _extend Mr: Btennanscoxztract to prowlide ongoingmonitoring -- on such matters as . ll" E-"tFd mt? -- . - us In on MASSACHUSETTS I SUFFOLK COUNTY BOARD on REGISTRATION - . . . IN PHARMACY In the Matter of .. - NEW ENGLAND Docket Nos. - Registration No. 2848 DS--05-O40 J. CADDEN, - License No. 21239. . CONSENT AGREEMENT the Board of Registration in Pharmacy ("Board") and NEW ENGLAND CENTER (Pharmacy Registration No. 2 848), located at 697 Waverly Road, in Framingham, Massachusetts ("Registrant"), and BARRY J. CADDEN, ("Licensee") Pharmacist License No. 21239 and Manager of Record of Registrant, do hereby stipulate and agree that the following information shallbe entered into and become a permanent part of the files of Registrant and Licensee which are maintained by the Board: - 1. The parties enter into this Consent Agreement ("Agreement") to resolve fl or . Nos. 2. The Registrant, Licensee and the Board stipulate and agree that thisifilgreernent is . 'settlement of complaints izelating to an adverse event complaint _repo'r_t investigated by the . United- States Food and Drug Z-'r'dn11n1' 'stration"for acetate preservative tree 80 mg/ml Suspension, and concerning the dispensing of Trypan Blue without a valid prescription ("the Complaints"). 3. The Regi'strant, licensee and the Board acknowledge that this Agreement is a nondisciplinary agreement not reported to the National Association of State Boards of Phannacy or other outside report agencies, except that the License-e's failure to fiilfill the requirements of paragraph 5 may result in the in1position_ of discipline by the~Board. . 4. In order to resolve these matters without further proceedings before the Board, the Registrant, the Licensee, and the Board agree that on the date of the execution ofi this Agreement by the Board ("l3ffeotiire Date") the Board will order that the Licensee be placed on Probation for a Period of One (1) Year, and the probationorder will be disputed matters Stayed for one (1) year from the Effective Date of this Agreement ("the Stay"), The Registrant and the Licensee agree asfollovvs: . 4 Within 45 days from the Eitective Date of this Ageetnent, the Registrant and Licensee shall provide documentation satisfactory to the Board that Boardwapproved evaluator: Pharmacy Support, Inc. or "Eva1uator"), at the expense of the: Registrant and Licensee, has conducted an inspection of and prepared a written' report analyzir1g_Registrant's compounding practices and compliance with United States Pharmacopeia Standard 795 Compounding Procednresand USP Standard 797 - stems Compounding Procedures, in. accordance vvith'247 CMR Standards"), with any recommendations for revisions to practice for compliance with USP"Star1dards ("the First Report''). The inspection shall include consideration of, but not be limited toSterile Environmental Design Qua.lityAssurance Program I Media Fills (operator qualification/process validation), iv. Environmental Monitoring V. Cleaning and Sanitizing Program vi. Training Records vii- Process Control Equipment ix. - Finished Preparation Testing Adverse Event Records The Registrant and Licensee will arrange for the Evaluator to provide a copy of the - First Report as described in Paragraph 5(a) directly to the Board within fourteen days of the insp eotion- The'Registrant and Licensee will implement all recommendations made by the 'Evaluator within 90 days of the Efiective Date of this Agreement. The Registrant and Licensee must petition and receive the approval of the Board to exemptor postpone implementafion of any particular recommendation. Within six months of the Effective Date of this Agreement, the Registrant and Licensee shall provide documentation satisfactory to the Board that the Evaluator, at the expense of the Registrant and Licensee, has conducted a second inspection of Registrant and prepared awritten report after an analysis as described in Paragraph (5) above, and finther, as to whether' the recommendations made by the Evaluator in the First Report have been implemented ("the Second Report'). The Registrant and Licensee _will arrange for the Evaluator to provide a copy of the Second Report as described in Paragraph 5(d) directly to the Board fourteen days of the inspection. - - - The Registrant and Licensee update Standard Operating Procedures ona biannual, I I0basis. The Registrant and Licensee will keep a written report of each adverse event reported and make such reports available for review by the Board upon request. - If the Registrant and Licensee successfully complete the requirements of paragraph 5, its registration and his license will not be placed on probation. .. if the Registrant and the Licensee fail to successfully complete the requirements of . paragraph .5, the Stay will be withdrawn by the Board and the Board's order of Prob aticn for a Period of 'One_(1) Year ("Probation") will be imposed upon the Registrant and Licensee Without the necessity of additional proceedings pursuant to G. L. c. BOA. The terms and conditions of Probation will be determined by the Board at that time and may include, but not be linnited topractice restrictions, monitoring conditions, appearances before the Board, and continuing education and training. This Agreement and its contents shall be incorporated into the records maintained by the Board. This Agreement and its contents are matters of public record, and are subject to disclosure without limitation to the 'public and equivalent state licensing boards. The Board agrees that in return forthe execution and fiilfillment of the requirements of this Agreement by the Registrant and Licensee, the Board will not advance the prosecution; of the Registrant and Licensee pursuant to the Complaints; anyand all other rights of the Board to take action the-scope of its authority are expressly reserved The Registrant and Licensee understand and agree that the failure to accept the terms of this Agreement shall nullify the representations contained herein, and permit the Board to 'initiate formal adjudicatory action under the State Administrative Procedure Act, G.--.- .1116 Registrant and Licensee understand and agree that?the decision to enter into this Agreement and to accept the terms and conditions herein described is a finalact and is not subject to reconsideration or judicial review. 5 The Registrant and Licensee state legal counsel has been consulted in connection with the . decision to enter into this Agreement_ and if not, that there was an opportunity to do so. The Registrant and Licensee certify this document entitled "Consent Agreement" has been read The Registrant and Licenseeunderstand that, by executing this Agreement, the Registrant and Licensee are waiving any right to a formal hearing with rights to confront and cross-examine Witnesses, to call witnesses, to present evidence, to testify on its own behalf, to contest the allegations, to present oral argument, to appeal to court in the event - of an adverse ruling, and all' otherrights set forth in GL. c. 30A and 801 CMR 1.01 et, seq. . IQODSIOOS .- ., NEW ENGLAEB CGMFOUNDING CENTER Bar_ryJ. Ca' Dinactar of &rImacj' Jc3_Lg BOARD EN Emmimcy y: 0 President ., fifi?ctiva Buantl Dec. No, 1210, 1211 Cart Mail No. .697 Waverly Road Supper; Inc. 909 Orchard Street Mundcicin 1- IL 60060 347.565.9229 0 847.566.4960 facsimile asossojs D8-05-040 -i January Dooi>Cor'reotive Action Process Complaint Handling Program - - Standard Operating-Procedu-res The assessment 'covered the following areas foifnon-sterile compounding: Personnel - Raw material controi_and.testing Compounding preparations Vaiidation of oriticai prooesses Environmentai Monitoring Beyond Use Dating - Standard Operating Procedures . - investigations-and Documentation - - P836. 1 of 2 This document contains information that is gonfideofial Any disizibofion or copying of this downgeot wfii1oui'psm'1issiori from PSI or the testspoosoris prohibited. I Pharmacy Support, Inc._ 909 Orchard Street 0 Mundoicin 0 IL 60060 847.566,9229 847.566.4960 fiacsimfic "Positive Comments - . The newly installed modular clean room is state of the art and is of operation and to prevent contamination. The facility is of suitable size and construction to facilitate cleaning, maintenance, and proper operations. Personnel interviewed have appropriate education or experience to perform assigned functions. There are an adequate number of employees to perform -and supervise the compounding operations. Equipment utilized is appropriate for compounding operations. - suf'ficient size and design for- proper . All lots of products are compounded in accordance with a prescription. Conciusion Although your facility has seen significant upgrades" in facility design for the sterile compounding operation, there were gaps' identified during the assessment therefore, it is the opinion of the auditors that your operation needs to be upgraded and enhanced to be in substantial compliance' with United States Pharmacopeia <795> or The auditors observed some of the compounding activities and although the technicians appeared/to be performing the operation adequately, without a written procedure to follow it is not known if the activity is repeatable and reliable; and as noted - throughout the report much of the documentation for the activities that is performed is inadequate. Upon implementation of the recommended corrective actions, we believe that appropriate systems will be in place and in compliance with the USP.standards. The recommended corrective actions are intended to address the systemic issue and not necessarily the isolated instances of non--compliance. The recommended corrective actions can be implemented in the specified time frame requested from the 3 State Board of Pharmacy. . . . lnadequatefincompiete documentation i.e. Good Documentation Practices are inadequate. 'Written' procedures are admittedly not routinely followed andior 8op's are not written.' in many cases the procedures are not in strict accordance with USP - End product testing is often performed on "stock solutions" and not the end product that is required. Process controls including validation of sterilization I. cyolesand media fills are 'inadequate. in a continuing effort to help keep management in compliance with the USP standards, is recommending that you consider hlringa qualified Quality Assurance professional who would take for maintenance of the newly developed quality systems. The alsselssment resyults have loeelny included for yourflrevievv. Ti' he resultshave been 'formatted into three sections: 1) specific USP req'ui_rement. 2) observation or non--cornpliance to each USP requirement highiightingspecific examples as evidence of the non-'compliance and 3) recommended corrective action. Sincerely, l'vlic'l< Morlva V.P. Quality Operatioris Pharmaceutical Systems, inc. . Ice: The Massachusetts Board in Registration in Pharmacy Ross A Capuio, Pharmacy Support, I-nc. Megan Jeffrey, Pharmacy Support, inc. . Page 2 of 2 This document contains infonnah'cn_ttrat is confidential and titty dislribution or copying ofthis permission ficm PSI or the test sponsor is p1_'o1u'bited. '5 Companytiontaot Greg Conigliaro and Barry Cadden Compounding Sterile and Non 'Sterile Preparations Observations and Recommendations Final Report . ,Company Name: New England Compounding Center Phone; Observations requiring Corrective Action Nori-Sterile Compounding . . - ote:'As discussed with' the Director of Pharmacy, this section -of the USP requirements has not been addressed by_ New England Compounding Center as'no current active procedures exist. Focus has been directed to the sterile side' of the 'operation. .By reviewing the Standard Operating Procedure index, the . auditors observed that although there are some procedures, the majority of them are not written explicitly -for meeting the requirements of USP <795>. None of that are written for the non-sterile operation are signed or approved. The list below is not intended to be all inclusive ofthe requirements of . <795>, but the-entire section of standards needs to be addressed formally. - Requirement - --Resiaonsibilitv. of the 'Cornpounder "Personnel are capable and qualified to perform their assigned duties." '0 been/ations"l . - I - There is no written/documented procedure (SOP) defining a training program for non-steriie . . compounding personnel. no documentation of training conducted. Recommendations program. Document requirements of the training program in an SOP. Document all training conducted - Conduct performance reviews at scheduled intervals to assure that processes continue to be carried out in acco-rclan'c'e with written procedures. Written 'and 'practica'l.exarns should be considered Periomn training in accordance with the requirements Observation 2 - . a),There_ is no written standard operating procedure to -definethe roles and. responsibilities of the compound er Spharrnecist as defined in <795>) to -assure quality- is built into the products to included key actors as outlined in the stan.c'iards.. I - A - Example: No written""proc'e'dures to'assure'c'ritical"process'es are "validated, No written procedure for stability program, No -written procedure detailing quality verifications to assure no compounding errors have occurred. Recommendations A. I . Formal standard operating procedures must be written to address compounders roles and responsibilities including all key factors as described in the standaids. Reguirement - USP <:795> . Comgounding Environment . f'Areas designated for compounding have adequate space for the orderly placement' of equipment and materials to prevent mix-ups between ingredients, containers, labels, in-process materials, and finished preparations. The compounding areais also to be designed, arranged, 'used, and maintained to prevent adventitious cross-contamination. -. "Equipmentandaccessories used in compounding are to be inspected, maintained, cleaned, and validated at appropriate intervals to ensure the accuracy and reliability of their perfo'nnance." '.Pharmacy Support, inc. . . . . Page 1 Of 11 . This document contains infoanadqn that is conficienfial and propdelary. Any distribution or copying of this - document wifinout permission firom PSI or the test sponsor is prohibited. Fjhone: see-3'20-osos Compounding Sterile and' Non Sterile Preparations Observations and Recommendations Final Report Company Name: New?England Compounding Center Company Contact Gregoohigliaro and Barry Cadden Observation 3 .. . -. a) There were visible residual chemicals built up on the inside of powder hoods. b) -Contamination control was not adequate in that there were uncovered containers observed on stir plates. . - - . in-process containerslwere not labeled and on the work bench d) There was' a large hole in one ceiling panel 'directly over a workbench -- e) Therea-re no written detailing the operation and use of equipment. f) There is no written cleaning or maintenance schedule for egulpment, including refrigerators, balances, capsule machines and hot plates. . jg) There is no written procedure that definesaction to be taken when temperatures are out of range. rnanufactures recom'ineri'dation's. I h) There is no documentation to indicate equipment is routinely verified or standardized prior to use. i) some equipment eideriors were visibly dirty with a build up residue, especially balances. 1-rrhs had Recommendations . . . - . - . . Establish an overall facility layout indicating process/materiallpeople flowto assure that the facility layout is.ac_lequate to prevent cross contamination of any kind. - - Establish a procedural requirement for cleaning of workspace and powder hoods. Protect materials from contamination by 'covering when appropriate. Each in--process container should be labeled with it's contents and status as appropriate Prepaie equipment calibration lo'gs'and temperature logs for each piece of equipment Each piece 'ofequlpment must be identified with aunique number and calibration status. Create specific eq 'pment SOPs for the use, maintenance and cleaning of all equipment based on . Review SOP's'and delete references to equipment manuals for calibration instructions_ 3 All thermometers should be.tra_ceabie to standards. Write procedures to detail requirements for equipment verification or standardization: Replace wash and chemical wash station with solutions .. Stability of Com'pounded'F?reparations preparations should be packaged in containers meeting USP standards", ".0-ompcunders are to consider the nature of the drug and its degradation mechanism, the container in which it is' packaged, the expected storage conditions, and the intended duration 'of therapy when assigning a I beyond use ..At all steps in the compounding, dispensing, and storage process, the compoundertsi to observe the compounded drug preparation for signs of instability. . "Federal law requires that 'manufactured drug products be labeled with an expiration date" Observations - a) There is no written SOP defining the stability program of non~steri1e_ preparations. "-Recommendation Establish a stability program Pharmacy Support, inc. Page 2 of it - This document contains informafion that is confidential and proprietary. Any dismbufion or copying ofthis . - - doctnnent witi_1ou.t permission flora or the 'test is proiubited. Company Name: New.England Center Compounding Sterile and Non Sterile Preparations Observations' and Recommendations Final Report 'Company Contact Greg Conigliaro and Barry Cadden Phone: Requirement - - ingredient Selection . "Only manufaciureddrugs from containers labeled with a batch control a future expiration date are acceptable. Observation 5_ a) ingredients were transferred to a secondary container with insufficient labeling. Recommendation _Label all bottles and pre--m-ix syringesappropriately. Requirement -- USP. .<795> compounded Preparations '5 Unless otherwise indicated or appropriate, compounded preparations are to be. prepared to ensure that 7 "each preparation shall contain not less than 90%'and not more than 1jl'i)% oi' the theoretically calculated I - dispensing. the storage requirements and any quality control procedures. Example: . 'and labeled quantity ofaotive ingredient perunit weight or volume and not lesstnan 90%_and not more Jfhan 110% of the theoretically calculated weight or volume per unit of the preparation" . . - Otiserllation There is nowritten SOP defining' release criteria to verify that each preparation shall contain not less . than 9.0% and not more than.1'i 1 Recommendation -Bequiremente USP 495:>> Compounding-Process: Thecompounders are to consider using thefollowing steps to minimize errorand maximize the prescribers intent..," - . - Observation - a) No requirementsfor donning proper attire or hand washing. .b)-There is no written SOP definingthe final appearance of the formulation as part of release of the preparation.' . . . - .F'2ecornme.ndat.io.n_ I Author SOP defining proper attire and hand washing. . Establish a program to verify 'release criteria_ including final appearance oiformulation, Reguirement-- USP - Comp ounding Records and Documents - - "This record must list the name, strength, and dosage form of the preparation compounded, ali- ingredlents and their quantifies, equipment needed to prepare the preparation, when appropriate, and mixing instructions. Mixing instructions should include the order of mixing, mixing temperaturesor other environmental controls,' such as duration of mixing, and other tat.-tors pertinent to the replication of the preparation as compounded. The forrnulation-must include the beyond~use date, -the container used in . ., . - . The fonnulatlon record is incomplete and/or not appropriately designed The mixing instructions are not specific and do not always indicate time and'temperature. Pnannacy support, inc. - r- ,P'age,'3'or11_ - This document contains information that is confidential, and proprietary. Any cfistrib1m'on or copying of this document without permission fi*c1_p PSI or rigs mt sponsor-is prohibi Edulprnent description or equipment number is not identified. - . Compounding?terile and Non ?terile Preparations Observations and Recommendatio'n3 Final Report Company Name: New England Compounding Center .. . I Company Contact Greg Ccnigliaro and Barrvcadden Phone: eoa--e2o~oeoc - . . \-mean' . . . . Environmental controls are not specified - No quality control procedures are defined Re'comm_endaticns= . . - List equipment and anyother instruments on formulation record. _-Update mixing instnictionswith ranges and times: 0 Cover white stirring. - an Example of enedequate mixing instruction, "The compound should be mixed on the hot 10-15 minutes. Do_cum_entte'mperature'and time on - - . - compoundingrecord." . . . List all safety, id-entity, strength, quality and purity information as applicableto the finish preparation. fleauirement - USP <795> Qualitv control 'To .ensure.accuracy_and compieteness, the compounder' -that;it appears as expected and is to investigate any discr - - - epancies and take appropriate corrective Observationia . . Thereare no (Corrective. Action and Preventative Action) or O08 (Out of Specification) _/"investigation written. - Recommendation . . is to observe the finished preperatiorrto-ensuure Reouirement - Verification' "The act of verification ofa compounding- procedure involves checking to ensure that calculations, . weighing and measuring, order of mixing, and compouncling.techniques were appropriate and accurately performed." Observation to - - - at) There are' no written procedures for finished preparation verification or 'release of preparation. Checks donot include ingredient, lot number, or expiration, check. Recommendation Develop a finished_ preparation SOP I . i . Develop a release SOP that-requires specific verifications and the documentation 1 Pharrnacy Supp'ort,lnc. . - . . Page 4 0f_11 - This dO0'lIIm3l1iC contains information that is confidential and proprietary. Any distribtrtion orcopying of'-this 'document without permission ficm PSI or the test sponsor is prohibited. . Compounding Center Develop a written procedure for incoming inspecfionrof raw materials. thus, stopperedand cn'rnped' empty vials must conta Verify methods. Such items are either used immediate'l al Report I Compounydihg Sterileand Non Sterile Preparations Observations and Recommendations Fin Company Contact Greg Conigliaro and Barry .Cadden - Phone: 508-820-0606 Sterilecompounding A . Re uirement --.USP Res _onsibilities of all com oundin . ersonnel - -"Opened or partiaiiy used 'packages of ingredients for subsequent use in OSPs-are properl stored under - restricted access conditions in the compounding facility. Such packages cannot be used when visual inspection detects unauthorized breaks in the container, ciosure, and seal; when thecontents do not possess the expected appearance, aroma, and texture; when the contents do not pass identification tests specified>> by the compounding facilityr,-and when either the beyond--use or expiration date has been exceeded." "Measuring; mixing, and purifying devices are-clean, appropriately accurate, and effective for their- intended uses." Qbsefvations '1 - . a) No documentation of inspection of incoming materials. Recommendations . Observation 2 a) Glassware/metal equipment used for CSPS is not depyrogenated before use._ Recommendations I Chan gg to requte_depry_ogenatio_n_gf_ Depyrogenate all glassware/metal eouipment.befor.'e use. . - Provide adequate storage space for depryogenated glassware when not used immediately :Requirernen't - USP -- in/erification of iiompoundinq-Accu racy and Sterilization Steam . . "To achieve sterility, it is necessary that ail materials beexposed to steam at 121?, under a pressure of about one atmosphere or_15_psi,- for the duration verified by testing to achieve sterility of the items, which is usually 20 to 60 minutes for Sealed containers-must be able to. generate steam internally; in a small amount of moisture to generate-steam." a) No documentation exists for the evaluation of appropriate sterilization method. - b) Sterilization equipment has not beezi verified.' c) No verfificafion that product reaches 121? for a minimum 15 minutes, d) Documentation of sterilization cycles is insufficient and/or incomplete. R'eccmm'endatiohs' Record pressure and-temperature with each cycle." Verify-load configurations. Dry Heat . . . - . . - - . "Glass and. metal devices may be covered with.alumir;1um foil. then exposed to dry heat in an oven at amean temperature of 250"for 2 hours to achieve sterility 'and depyrogenation (see DiylHeat Sterilizer tion under .8terillzation and Sterility Assurance of Compendial Articles, USP Chapter - or-stored until use in an environment suitable for com pounding and -Pharmacy Support, Inc. . . Page 5 of 'it This document contains that is confidcnfial and proprietary. Any distribution or copying of this clocument-without pezmissioztfiom PSI or the test sponsorjs prohibited. Compounding Sterile and Non and Recommendations Final Report Company Name: New England Compounding lcenter 7 Company Contact: Greg Conigliaro and Barry Gadden .Phone: sosuszo-ococ - Observation glassware is not perfonned or documented. b) No documentation for sterilization cycles. c) Sterilization equipment has not been verified. Recommendations 'Glassware used in high risk compounding must be depyrogenated and stored appropriately. Verify sterilization methods. Filtration - - "Commercially available sterile filters must be approved for human--use applications in sterilizing pharmaceutical fluids. Both filters that must be sterilized before processing CSPs and those filters that are commercially available, 'disposable, sterile. and pyrogen-free have a nominal porosity of 0.2 urn, which inciudes'0'.22~ pm - "Personnel ascertain from appropriate information sources 'that the sterile mioroporous membrane filter used to sterilize CSP solutions, eitherduring compounding or administration, is chemically and physically -compatible with the . -. Observatio Commercially avaiiablefilter devices are not documented 'to be receivedwith certification of analysis. No.writle,n procedure for sterilization by filtration. point Filter' compatibility is not'docum.ented. Recommendations - Retain Certificates of Analysis-of filters for records.' -- 'Better documentation for sterilization by filtration. Document and verify filter compatibility. Requirement .- USP <797:> - Personnel Training and Evaluation in A-septic ivianipuiation Skills "Media--fi|i testing is used to assess the quality-of the aseptic skill of compounding personnel. Media-fill tests represent the-most challenging or stressiuiconditions actually encountered by the personnel being evaluated when they prepare' particular risk level C8Ps and whenosterilizing _high-risk-level - Q_lase_I1e.ti_0n? . . a) Media fill acceptance criteria has not been defined.' Corrective action for media fill failure has not been defined (performed). c) Media fill protocols are incornpiete in that - - Media fill final reports documenting results are not completed. d) 'Appropriate interventions during -media fills are not defined. e) No Environmental Monitoring taken during media fills. t) No growth promotion documentationof media fills media. 9) Media fill procedures are inadequate and inconsistent - . -Process validafion media fills do not contain the-proper number of containers. Recommendations Process media "fills mimic actual process. . . - . Media-fills must be preform-ed at the frequency defined in USP (annual~low/medium, semiannual- high). Me'clia~fili protocols should -be established in that - EM s-aifnpling is conducted during the media fill. EM sampling must include sampling of personnel and surfaces as well as viable and non-viable air sampling._ Pharmacy Support, inc. - Page 5 Of This document contains infoutnation that is confidential and propiietlixy. Ahoy disifibuficm or copying ofthis without permission from PSI or the test is prohibited. .P -Compounding. Sterile and Non Sterile Preparations-Observationsand Recommendations Final Report I Company Name: New England Compounding Center Company Contact Greg Conigliaro and Barry Gadde Phone: 508-820-0606 Media fill final reports should-be' written documenting results. Appropriate interventions during media fills need to be defined. Media fills cover multiple container/closure sizes. . i . . Corrective action for media fill failure needs to be defined. 3 I Requirement - use <797> -'Environmental Quality and Control . "The surfaces of ceilings, walls, floors, fixtures, shelving, counters, and cabinets in in e;bul-fer area should . be smooth, impervious, free from cracks and 'crevices, and non-shedding, thereby promoting cieanability spaces in which microorganisms and other contaminants may accumulate." "Primary environmental control must provide at least I80 Class 5 quality of air to which sterile ingredients and cornponents of are directly exposed." "Only approved cleaning and sanitizing agents. are used with careful consicleration~of compatibilitles,- effectiveness, and inappropriate or toxic in the enter-oom area, supplies and equipment removed from shipping cartons are wiped with a sanitizing agent, such as sterile 70% alcohol (IPA), which is checked periodically .for contamination." "Personnel are critical keys to the maintenance of asepsis-when carrying out their assigned. . responsibilities. They must be thoroughly trained-in aseptic techniques and be highly motivated to maintain these standards each time they 'prepare a 'sterile product" .- "E_valuation of environmental qual'rty'is performed bymeasuring both the total number of particles and the; number of viable microorganisms in the controlled air environments of the compounding area." Furthermore, airsampiing is performed at. locations judged by compounding personnel to be the most-prone to contamination during compounding activities: this includes zones of air backwash "'Tir5uEfice within backwash turbuleh area." Observation - Schedule for cleaning is notas per USP <797>. . b) Floors in the buffer area have not been sanitized 'in 3 months of use. ets adjacent-to glove boxes have not been sanitized in Smonths of use.- Stereo in hybridbutferarea. - Recommendations I - . Remove all unnecessary items from the hybrid bufterarea stereo>> . - include all-items in hybrid buffer area on -the cleaning schedule-.~ - Floors should be mapped daily - Shelving units should be cleaned weekly - Walls and Ceilings should be Include shelving units on the cleaning schedule. They should be cleared off and wiped down. Observatloi_1_8 . - - a) Compounding area not certified to be ISO Class 5 during dynamic conditions. b) We-ibis holes on glove box gloves.- 4 ou_t,of the 3 gloves observed' had holes while CSP was compounded. Recommendations All 'classified areas must be certified during dynamic conditions. 'Observation9 a) Non-sterile is used to sanitize. - b) Non-sterile 70%! PA is notperiodlcally checked for contamlnation.. Pharrnacy Support, inc. . - Page 7 of'11 . This 'document contains infonnafion that is confidential and dislribufion or copying of this .- docmnent vrithout pottnission _fiom or the test sponsdris prohibited. .Gompounding Sterile and Non Sterile Preparations Observations and Recommen?lations Final Report - Company. Name: New England Compounding Center Company Contact: Greg Gonlgiiaro and Barry Cadden ;P,hone: 508,-820-sacs - . R-eoommendation's -, Bleach or other appropriate sporocicle should be used for cleaning on a weekly/quarterly basis, especially for incubators and refrigerators. - . Utilize -sterile 'r'0%lPA. Observation 10 - a) Hairnets and beardcovers were not worn properly. ii) 'Gowning procedure is not established. - c) Beard covers not worn, a) Shoe covers not worn. Recommendations . . . . . - Personnel should be gown certified to work in the hybrid buffer area. This would include microbial samples-of personriel.. Hairn-ets must cover all hair and ears. . . Beard covers must be worn while compounding; There should be a procedure for the cleaning of scrubs and lab coats. . Qbaemfioali . . . a) 'Environmen'tal data is not documented properly. - - b) Environmental monitoring procedures are inadequate. me). Environmental monitgrin %e when there is an action . - level reached. . Recomrnendations - All class 100 1 ISO -5 microbial recovery should be identified to the genus and spent Environmental monitoring program personnel fingertip plates. - Environmental monitoring procedure must be 'updated to Include corrective actions for out of specification results. . Procedures for tracking and trending data need to be established. as level. .R_enuirenient - USP Processing Equipment . . "iris n"ec'essary th at equipment," apparatusfand devicesused to"-compound--a C9-P are consistently- capable of operating properly and within acceptable tolerance limits. Written procedures outlining 'req'u-ired" equipment calibration, annual maintenance, monitoring for proper function, controlled procedures for use of the-equipment and-specified time frames' for these aotivities'are._ established and followed." Observa'tion 12 a) There is no written .sOP's for calibration/preventative maintenance of_- autoclaves, dishwasher, isolator, freezers "or-Baxa pumps. -- . . b) Calibrations are not perfonned properly. Not verified against a certified standard c)_No' written preventative maintenancelclearring schedules established for equiprgnent. . No written requirements/corrective actions established for out of tolerance readings. Rewmmendafion . - - Author SOPs that include equipment, use, maintenance and calibration. - . Author SOPs to include cleaning schedules. - - actions need to be defined and documented. Phannaoy Support, inc. . . - v_Pa'ge'8 .01' 11 This docnmerrt contains infonnati on that is confidential and proprietary. Any.disi1-ibutiqn or copying of this - without pennission fiom PSI sponsor. prohibited. . . Company Name: New England Compounding Center applicable. Recommendations . - Compounding Sterile and Non Sterile Preparations Observations Final Report Gem-pany Contact-Greg. Conigiiaro and Barry Cadden . Phone: Requirement <7s7> - Finished Preparation Release Checks and Tests "All CSF's for administration by injection into the vascular and central nervous systems that - are prepared in groups of more than 25'identicai lndividu_ai single~dose.packages, or in multiple dose vials for administration to multiple patients, or are exposed longer than 12 hours at 2? to 8? and longer-than 6 i hours at warmer than 8?-before they are sterilized are tested to ensure that theyare sterile.(see Sterility Tests and do notcontain excessive. bacterial endetoxins (see Endotoxins "Finished CSPs are individually inspected in accordancewith written procedures after compounding. lf. not distributed these products are individually inspected just prior to leaving the storagearea. . Those products that are distributed are stored" in an appropriate location as described in black background' or both' for evidence of .th'e'-written procedures. immediately after' compounding and as a condition of release, each product unit, - where possible, should be inspected against lightedwhite or a visible particulates oroth er foreign matter." Observation 13 - . a) 'Stei=ility testing is not being perfornjiedper USP <71> b) The testing laboratory has 'not,bee,n surveyed to ensure sterility and endotoxin testing is completed per. the applicabie_USl'j' methods', Tests Endotoxin Test chemistry tests as _-Veri.fv - - i . Sterility testing is contracted out to an' outside laboratory, although not required, it is highly . recommend that there be an audit facility to ensure their adherence to" USP and requirements for testing. 'Observation 14 5 . a) Nd written procedure for final inspection, b) No documentafion of quarantined area. - No documentation of release ofpreparation from quarantine. 1' 'Recommendations - Establish a final inspection procedure. Author SOP5 for quarantine and release of final'pre'pa'rations. Requirement - USP '<797>f - Storage and B?vondwuse fiatinq - - "Beyond-use dates for C8Ps'that are prepare strictly in, accordance with manufactures! product labeling must be those-specified in that labeling, or from appropriate literature sources or directtesting.-" Observation 15 a) BUD assigned incorrectly. Recommendations . . . . - -Revise BUD assignment to reflect what is defined in USP <797> or provide stability studies. Re ualin AssurancePro ram. . I Program intended to provide a provider of C8Ps must have in place a formal Quality Assurance (CIA) . mechanism" for monitoring, evaluating, correcting, and improvingthe activities and processes described in this chapter (USP. -Pharmacy Support,' inc. I - . . Flags 9 of 11 This docun-rent contains informafiosl that is confidentiai and pmpfictaiy. Any distribution of copying of this docurocnt without permission from or the test sponsor is prohibited; -s Compounding sterileand Non Sterile Preparations Observations and Recommendations Final Report. Gornpany Name: New England Compounding Center Company Contact: Greg Conigliaro and Barry Cadden Phone: sos-s2.oLoeoe I 'Qbse'rvation"l6 I . . . . va) -There are no written procedures for receipt, storage, and accountability of controlled substances. b) There is no written procedure for Good Documentation Practices. c) Good Documentation Practices are not foilovved; No written procedure for Deviations, investigations and Correci2'veIPreven_tative Actions When temperature monitoring was not performed/documented or temperature wasout of range, there was no deviation opened', investigation or Corrective/Preventative action-put . inplace.- . e) Failure/O08 procedures for final release are insufficientinvestigation for finished preparation testing failures, i.e. potency was above - specifioation'an.d releasedwritten procedure for how to use/complete formula worksheets. g) No change control-procedures - h) SOPs are inadequate or not followed. 'Recommendations <