FDA Inspection 779008 — Almirall Hermal GmbH
The FDA completed an inspection of Almirall Hermal GmbH on April 13, 2012 in Reinbek. 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
- April 13, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Reinbek (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |