FDA Inspection 982630 — Svizera Labs Private Ltd
The FDA completed an inspection of Svizera Labs Private Ltd on Jul 21, 2016 in Thane. 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). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 21, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Thane (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3614 | 21 CFR 211.160(b)(4) | Written calibration procedures |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |