FDA Inspection 1109599 — Pfizer Ireland Pharmaceuticals Unlimited Company
The FDA completed an inspection of Pfizer Ireland Pharmaceuticals Unlimited Company on November 12, 2019 in Dublin 22. 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: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 12, 2019
- Fiscal Year
- 2020
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Dublin 22 (Ireland)
Citations
| ID | CFR | Description |
|---|---|---|
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 9086 | 21 CFR 600.14(a)(1) | Who must report - manufacturer |