FDA Inspection 1019905 — Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer, Inc.
The FDA completed an inspection of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer, Inc. on July 27, 2017 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 27, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rouses Point, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1256 | 21 CFR 211.68(b) | Backup file not maintained |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |