FDA Inspection 1210984 — Zoetis Manufacturing & Research Spain, S.L.
The FDA completed an inspection of Zoetis Manufacturing & Research Spain, S.L. on Jul 28, 2023 in La Vall De Bianya. 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). 3 citations were issued during this inspection. Product area: Veterinary.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 28, 2023
- Fiscal Year
- 2023
- Product Type
- Veterinary
- Project Area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Location
- La Vall De Bianya (Spain)
Citations
| ID | CFR | Description |
|---|---|---|
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |