FDA Inspection 1009383 — Intervet GesmbH
The FDA completed an inspection of Intervet GesmbH on March 10, 2017 in Vienna. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 10, 2017
- Fiscal Year
- 2017
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Vienna (Austria)
Citations
| ID | CFR | Description |
|---|---|---|
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |
| 3569 | 21 CFR 211.89 | Quarantine of Rejected Components et. al. |
| 3641 | 21 CFR 211.204 | Record information inclusions |
| 4410 | 21 CFR 211.194(a)(5) | Calculations performed are in the records |