FDA Inspection 837463 — Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer, Inc.
The FDA completed an inspection of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer, Inc. on June 21, 2013 in Rouses Point, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 21, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rouses Point, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |