FDA Inspection 996114 — Vet Pharma Friesoythe GmbH
The FDA completed an inspection of Vet Pharma Friesoythe GmbH on September 13, 2016 in Friesoythe. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 13, 2016
- Fiscal Year
- 2016
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Friesoythe (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1933 | 21 CFR 211.167(a) | Sterility/pyrogens - test methods written, followed |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |