Warning letter
Seaway Pharma Inc.: warning letter of Dec 1, 2025
FDA warning letter 717355 · Office of Manufacturing Quality
Key facts
| Reference number | 717355 |
|---|---|
| Company | Seaway Pharma Inc. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Dec 1, 2025 |
| Posted date | Dec 9, 2025 |
| Issuing office | Office of Manufacturing Quality |
| Product type | Drugs |
| CFR sections cited | 211.165(a), 211.22(d), 211.34, 211.84(d)(1), 211.100(a), 211.194(a) |
| Inspection city | Massena |
| Inspection ZIP | 13662 |
| Inspection start date | May 19, 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: