FDA Inspection 733401 — KVP Pharma Veterin Produkte GmbH
The FDA completed an inspection of KVP Pharma Veterin Produkte GmbH on Jun 17, 2011 in Kiel. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 8 citations were issued during this inspection. Product area: Veterinary.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 17, 2011
- Fiscal Year
- 2011
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Kiel (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |