FDA Inspection 1066861 — Rovi Pharma Industrial Services S.A.
The FDA completed an inspection of Rovi Pharma Industrial Services S.A. on Sep 14, 2018 in Alcala De Henares. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 14, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Alcala De Henares (Spain)
Citations
| ID | CFR | Description |
|---|---|---|
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |