FDA Inspection 931397 — Haupt Pharma Wuelfing GmbH
The FDA completed an inspection of Haupt Pharma Wuelfing GmbH on Jun 16, 2015 in Gronau (Leine). 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). 4 citations were issued during this inspection. Product area: Veterinary.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 16, 2015
- Fiscal Year
- 2015
- Product Type
- Veterinary
- Project Area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Location
- Gronau (Leine) (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4378 | 21 CFR 211.188(b)(2) | Identity of major equipment and lines used |