FDA Inspection 1064488 — J. B. Chemicals and Pharmaceuticals Limited
The FDA completed an inspection of J. B. Chemicals and Pharmaceuticals Limited on August 24, 2018 in Anklesvar. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 24, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Anklesvar (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |