Drug factory · FDA FEI 1942094
Alcami Carolinas Corporation
4260 Forest Park Avenue, St. Louis, MO, United States
Problems found, fixed voluntarily at FDA's last inspection, Oct 4, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
7 drug inspections on record since 2009: 2 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Buprenorphine and Naloxone | Tests it | Indivior Inc. | 12496-1202, 12496-1204, 12496-1208 +1 |
| Gemcitabine | Tests it | Janssen Biotech, Inc. | 57894-225 |
| Methadone | Tests it | Breckenridge Pharmaceutical, Inc. | 51991-002 |
| Morphine | Tests it | Nortec Development Associates, Inc. | 42689-005, 42689-006, 42689-007 +3 |
| Peramivir | Tests it | BioCryst Pharmaceuticals, Inc. | 72769-181 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 4, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 16, 2020 | No problems found | Drug Quality Assurance | — |
| Mar 28, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Jan 14, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 31, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 3, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 20, 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.
Mar 28, 2017 inspection
- Following/documenting laboratory controls 21 CFR 211.160(a)
Established laboratory control mechanisms are not followed. - 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.
Registered with FDA for: analysis.