FDA Inspection 935372 — Umforana GmbH & Co. KG
The FDA completed an inspection of Umforana GmbH & Co. KG on Jun 16, 2015 in Wiesbaden. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 16, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Wiesbaden (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |