FDA Inspection 841520 — Intervet International GmbH
The FDA completed an inspection of Intervet International GmbH on July 16, 2013 in Unterschleisheim. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 16, 2013
- Fiscal Year
- 2013
- Product Type
- Veterinary
- Project Area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Location
- Unterschleisheim (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 4576 | 21 CFR 211.192 | No written record of investigation |