FDA Inspection 887446 — Siegfried Hameln GmbH
The FDA completed an inspection of Siegfried Hameln GmbH on July 25, 2014 in Hameln. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 25, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hameln (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |