FDA Inspection 1015159 — Vovantis Laboratories Private Limited
The FDA completed an inspection of Vovantis Laboratories Private Limited on June 9, 2017 in Vadodara. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 9, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Vadodara (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3557 | 21 CFR 211.52 | Washing and toilet facilities are deficient |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |