FDA Inspection 1295786 — Wyeth Pharmaceutical Division of Wyeth Holdings LLC
The FDA completed an inspection of Wyeth Pharmaceutical Division of Wyeth Holdings LLC on December 17, 2025 in Pearl River, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 17, 2025
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pearl River, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1803 | 21 CFR 211.84(b) | Representative Samples Criteria |
| 2399 | 21 CFR 211.194(a)(2) | Laboratory Test Method Verification |
| 4320 | 21 CFR 211.84(d)(6) | Microbiological Contamination Exam |