Drug factory · FDA FEI 1000158582
Alcami Carolinas Corporation
4620 Creekstone Drive, Durham, NC, United States
No problems found at FDA's last inspection, Dec 6, 2024.
No Action Indicated: inspectors found no objectionable conditions.
4 drug inspections on record since 2011: 2 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Omidubicel and Omidubicel Non-Cultured Fraction | Tests it | Gamida Cell Inc. | 73441-800 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 6, 2024 | No problems found | Bioresearch Monitoring | — |
| Mar 13, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 23, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 24, 2011 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis.