FDA Inspection 1200704 — Vet Pharma Friesoythe GmbH
The FDA completed an inspection of Vet Pharma Friesoythe GmbH on March 24, 2023 in Friesoythe. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 24, 2023
- Fiscal Year
- 2023
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Friesoythe (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 21536 | 21 CFR 514.80(b)(1) | Applicant did not submit/submitted late 3-Day Field Alert Report or wrong format |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |