FDA Inspection 876712 — Haupt Pharma Wolfratshausen GmbH
The FDA completed an inspection of Haupt Pharma Wolfratshausen GmbH on March 18, 2014 in Wolfratshausen. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 18, 2014
- Fiscal Year
- 2014
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Wolfratshausen (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |