FDA Inspection 1117866 — Pharbil Waltrop Gmbh
The FDA completed an inspection of Pharbil Waltrop Gmbh on Feb 14, 2020 in Waltrop. 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 14, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Waltrop (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |