Warning letter
Akan Biosciences, Inc.: warning letter of Apr 30, 2024
FDA warning letter 654674 · Office of Biological Products Operations – Division I
Key facts
| Reference number | 654674 |
|---|---|
| Company | Akan Biosciences, Inc. |
| Subject | CGMP/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | Apr 30, 2024 |
| Posted date | May 21, 2024 |
| Issuing office | Office of Biological Products Operations – Division I |
| Product type | Biologics |
| CFR sections cited | 1271.85(a), 210, 312, 211.42(c)(10)(iv), 211.100(a), 1271, 1271.15, 1271.3(c), 1271.3(f)(1), 1271.10(a), 1271.10(a)(1), 1271.10(a)(2) and 8 more |
| Inspection city | Gaithersburg |
| Inspection ZIP | 20879 |
| Inspection start date | Sep 20, 2022 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: