FDA Inspection 1211227 — Apothecon Pharmaceuticals Private Limited
The FDA completed an inspection of Apothecon Pharmaceuticals Private Limited on July 28, 2023 in Taluka Padra, Vadodara. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 28, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Taluka Padra, Vadodara (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3175 | 21 CFR 820.186 | QSR |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |