Drug factory · FDA FEI 1049418
Alcami Carolinas Corporation
1519 North 23rd Street, Wilmington, NC, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 26, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
33 drug inspections on record since 2009: 8 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Aprepitant | Packages it and labels it | Heron Therapeutics, Inc. | 47426-201, 47426-401 |
| Azathioprine | Packages it | Glenmark Pharmaceuticals Inc., USA, Oceanside Pharmaceuticals., Salix Pharmaceuticals, Inc. | 68462-502, 68682-231, 68682-241 +2 |
| Fexinidazole | Packages it and labels it | Sanofi-Aventis U.S. LLC | 0024-4512 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 26, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 9 |
| Sep 26, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 9 |
| Sep 26, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 9 |
| Feb 18, 2021 | No problems found | Drug Quality Assurance | — |
| Feb 18, 2021 | No problems found | Drug Quality Assurance | — |
| Feb 18, 2021 | No problems found | Drug Quality Assurance | — |
| Mar 7, 2019 | No problems found | Bioresearch Monitoring | — |
| Mar 7, 2019 | No problems found | Bioresearch Monitoring | — |
| Mar 7, 2019 | No problems found | Bioresearch Monitoring | — |
| Jan 29, 2019 | No problems found | Drug Quality Assurance | — |
| Jan 29, 2019 | No problems found | Drug Quality Assurance | — |
| Jan 29, 2019 | No problems found | Drug Quality Assurance | — |
| Feb 10, 2017 | No problems found | Drug Quality Assurance | — |
| Feb 10, 2017 | No problems found | Drug Quality Assurance | — |
| Feb 10, 2017 | No problems found | Drug Quality Assurance | — |
| Aug 19, 2016 | No problems found | Drug Quality Assurance | — |
| Aug 19, 2016 | No problems found | Drug Quality Assurance | — |
| Aug 19, 2016 | No problems found | Drug Quality Assurance | — |
| Jul 16, 2014 | No problems found | Drug Quality Assurance | — |
| Jul 16, 2014 | No problems found | Drug Quality Assurance | — |
| Jul 16, 2014 | No problems found | Drug Quality Assurance | — |
| May 3, 2013 | No problems found | Drug Quality Assurance | — |
| May 3, 2013 | No problems found | Drug Quality Assurance | — |
| May 3, 2013 | No problems found | Drug Quality Assurance | — |
| Mar 27, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 27, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 27, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 26, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 26, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 26, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 4, 2009 | No problems found | Drug Quality Assurance | — |
| Dec 4, 2009 | No problems found | Drug Quality Assurance | — |
| Dec 4, 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.
Sep 26, 2025 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions. - SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions. - SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions. - Procedures for non-sterile drug products 21 CFR 211.113(a)
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established. - Procedures for non-sterile drug products 21 CFR 211.113(a)
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established. - Procedures for non-sterile drug products 21 CFR 211.113(a)
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Registered with FDA for: label; manufacture; pack.