FDA Inspection 1021237 — Milan Laboratories (India) Pvt Ltd
The FDA completed an inspection of Milan Laboratories (India) Pvt Ltd on Aug 4, 2017 in Panvel. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 4, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Panvel (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 3557 | 21 CFR 211.52 | Washing and toilet facilities are deficient |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |