FDA Inspection 1043981 — Wilson Medicine Company
The FDA completed an inspection of Wilson Medicine Company on Mar 1, 2018 in Palghar East. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Mar 1, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Palghar East (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1251 | 21 CFR 211.42(c)(1) | Incoming material area |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1978 | 21 CFR 211.182 | Personnel dating/signing equipment log |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |