FDA Inspection 1197326 — Goodcare Pharma Pvt. Ltd.
The FDA completed an inspection of Goodcare Pharma Pvt. Ltd. on February 13, 2023 in West Bengal. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 13, 2023
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- West Bengal (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15425 | 21 CFR 111.15(i) | Hand-washing facilities |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15939 | 21 CFR 111.105(g) | Quality control - reserve samples |