FDA Inspection 1233212 — First Time US Pharmaceuticals (India) Pvt Ltd.
The FDA completed an inspection of First Time US Pharmaceuticals (India) Pvt Ltd. on Mar 14, 2024 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). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 14, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Navi Mumbai (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |