FDA Inspection 1115640 — Watson Pharma Private Limited
The FDA completed an inspection of Watson Pharma Private Limited on Jan 23, 2020 in Verna. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 23, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Verna (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |