FDA Inspection 678492 — Pfizer Inc
The FDA completed an inspection of Pfizer Inc on August 31, 2010 in Peapack, NJ. 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
- August 31, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Peapack, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 8907 | 21 CFR 314.81(b)(1)(ii) | Contamination, chemical or physical change, deterioration |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |