FDA Inspection 1259779 — Rovi Pharma Industrial Services S.A.
The FDA completed an inspection of Rovi Pharma Industrial Services S.A. on Jan 31, 2025 in San Sebastian De Los Reyes. 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 31, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- San Sebastian De Los Reyes (Spain)
Citations
| ID | CFR | Description |
|---|---|---|
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 2014 | 21 CFR 211.188(b)(2) | Identification of Equipment and Lines |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |