FDA Inspection 1295786 — Wyeth Pharmaceutical Division Of Wyeth Holdings LLC
The FDA completed an inspection of Wyeth Pharmaceutical Division Of Wyeth Holdings LLC on Dec 17, 2025 in Pearl River, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 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 |