Drug factory · FDA FEI 1000110990
Alcami Carolinas Corporation
4221 Faber Place Drive, Charleston, SC, United States
Problems found, fixed voluntarily at FDA's last inspection, Feb 6, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
9 drug inspections on record since 2009: 5 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Aprepitant | Makes it | Heron Therapeutics, Inc. | 47426-201, 47426-401 |
| Dantrolene | Makes it | Eagle Pharmaceuticals, Inc. | 42367-540 |
| Fosdenopterin | Makes it | Sentynl Therapeutics, Inc. | 42358-295 |
| Ibuprofen | Makes it | Prasco Laboratories, Recordati Rare Diseases, Inc. | 66993-490, 55292-122 |
| Tagraxofusp | Makes it | Stemline Therapeutics, Inc. | 72187-0401 |
| Triamcinolone Acetonide | Makes it | Bausch & Lomb Incorporated | 24208-040 |
| Verteporfin | Makes it and packages it | Bausch & Lomb Incorporated, Bausch Health US, LLC | 24208-560, 0187-5600 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 6, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 6 |
| Oct 29, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 15, 2018 | No problems found | Drug Quality Assurance | — |
| Dec 15, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 16, 2016 | No problems found | Drug Quality Assurance | — |
| Dec 20, 2013 | No problems found | Drug Quality Assurance | — |
| May 17, 2013 | No problems found | Drug Quality Assurance | — |
| Mar 23, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 17, 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.
Feb 6, 2026 inspection
- In-process materials characteristics testing 21 CFR 211.110(c)
In-process materials are not tested for quality and approved or rejected by the quality control unit during the production process. - 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. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. - Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. - Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use. - Written procedures fail to include 21 CFR 211.67(b)
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used and instructions for removal or obliteration of previous batch identification.
Registered with FDA for: analysis; manufacture.