FDA Inspection 1187304 — Eurovet Animal Health B.V.
The FDA completed an inspection of Eurovet Animal Health B.V. on October 25, 2022 in Bladel. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 25, 2022
- Fiscal Year
- 2023
- Product Type
- Veterinary
- Project Area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Location
- Bladel (Netherlands)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1174 | 21 CFR 211.42(b) | Product flow through building is inadequate |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 21297 | 21 CFR 211.186(a) | Master production and control records, procedure |
| 2399 | 21 CFR 211.194(a)(2) | Laboratory Test Method Verification |