FDA Inspection 1109599 — Pfizer Ireland Pharmaceuticals Unlimited Company
The FDA completed an inspection of Pfizer Ireland Pharmaceuticals Unlimited Company on Nov 12, 2019 in Dublin 22. 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 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 |