FDA Inspection 1259106 — Gopaldas Visram & Company Ltd.
The FDA completed an inspection of Gopaldas Visram & Company Ltd. on Jan 24, 2025 in Navi Mumbai. 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
- Jan 24, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Navi Mumbai (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |