Warning letter
Pharmathen International S.A.: warning letter of May 27, 2026
FDA warning letter 723680 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 723680 |
|---|---|
| Company | Pharmathen International S.A. |
| Subject | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Issue date | May 27, 2026 |
| Posted date | Jun 16, 2026 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| CFR sections cited | 211.160(a), 211.192, 211.42(c)(10), 211.113(b), 211.34 |
| Inspection city | Rodopi |
| Inspection start date | Nov 10, 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: