Drug factory · FDA FEI 1000142940
Alkermes, Inc
265 Olinger Circle, Wilmington, OH, United States
Problems found, fixed voluntarily at FDA's last inspection, Oct 19, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
10 drug inspections on record since 2009: 7 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Aripiprazole | Makes it and tests it | Alkermes, Inc. | 65757-401, 65757-402, 65757-403 +2 |
| Naltrexone | Makes it | Alkermes, Inc., Amneal Pharmaceuticals | 65757-300, 65757-301, 69238-2794 |
| Risperidone | Makes it | Janssen Pharmaceuticals, Inc. | 50458-306, 50458-307, 50458-308 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 19, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 7 |
| Aug 14, 2017 | No problems found | Drug Quality Assurance | — |
| Apr 17, 2015 | No problems found | Drug Quality Assurance | — |
| Aug 15, 2014 | No problems found | Drug Quality Assurance | — |
| Apr 23, 2014 | No problems found | Drug Quality Assurance | — |
| Sep 23, 2013 | No problems found | Drug Quality Assurance | — |
| Jun 28, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jun 29, 2012 | No problems found | Drug Quality Assurance | — |
| Nov 4, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 23, 2009 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Oct 19, 2023 inspection
- Validation lacking for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the process. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components, drug product containers, closures, in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity. - Complaints reviewed by Quality Control Unit 21 CFR 211.198(a)
Written procedures describing the handling of complaints do not include provisions for a determination as to the need for an investigation of any unexplained discrepancy. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. - Training--operations, GMPs, written procedures 21 CFR 211.25(a)
Employees are not given training in the particular operations they perform as part of their function. - Backup file not maintained 21 CFR 211.68(b)
Failure to maintain a backup file of data entered into the computer or related system. - Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Jun 28, 2013 inspection
- Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
Registered with FDA for: analysis; manufacture.