FDA Inspection 851739 — Vet Pharma Friesoythe GmbH
The FDA completed an inspection of Vet Pharma Friesoythe GmbH on August 27, 2013 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
- August 27, 2013
- Fiscal Year
- 2013
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Friesoythe (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1163 | 21 CFR 211.28(b) | Habits of good sanitation & health |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1933 | 21 CFR 211.167(a) | Sterility/pyrogens - test methods written, followed |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 4307 | 21 CFR 211.80(d) | Status of Each Lot Identified |