FDA Inspection 1015908 — Almirall, S.A.
The FDA completed an inspection of Almirall, S.A. on May 12, 2017 in Sant Feliu de Llobregat. 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
- May 12, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sant Feliu de Llobregat (Spain)
Citations
| ID | CFR | Description |
|---|---|---|
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 3609 | 21 CFR 211.160(b)(2) | In-process sample representation/identification |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |