Warning letter
Owen Biosciences, Inc.: warning letter of Oct 30, 2025
FDA warning letter 710275 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 710275 |
|---|---|
| Company | Owen Biosciences, Inc. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Oct 30, 2025 |
| Posted date | Nov 25, 2025 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| CFR sections cited | 211.160(b), 211.166(a), 211.192, 211.180(e), 210, 211.22, 211.22(d), 211.34 |
| Inspection city | Baton Rouge |
| Inspection ZIP | 70809 |
| Inspection start date | Mar 25, 2025 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 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: