FDA Inspection 1200759 — Sanovel Ilac Sanayi Ve Ticaret A.S.
The FDA completed an inspection of Sanovel Ilac Sanayi Ve Ticaret A.S. on March 24, 2023 in Silivri. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 24, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Silivri (Turkey)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |