FDA Inspection 1007848 — EuroAPI Hungary Ltd.
The FDA completed an inspection of EuroAPI Hungary Ltd. on Mar 3, 2017 in Budapest. 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
- Mar 3, 2017
- Fiscal Year
- 2017
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Budapest (Hungary)
Citations
| ID | CFR | Description |
|---|---|---|
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4410 | 21 CFR 211.194(a)(5) | Calculations performed are in the records |