FDA Inspection 1032397 — Jell Pharmaceuticals Pvt. Ltd.
The FDA completed an inspection of Jell Pharmaceuticals Pvt. Ltd. on December 1, 2017 in Silvassa. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 1, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Silvassa (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1794 | 21 CFR 211.80(d) | Disposition recorded by lot identification |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 4387 | 21 CFR 211.198(a) | Reporting of adverse drug experience to FDA |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |