FDA Inspection 1181052 — Torrent Pharmaceuticals Limited
The FDA completed an inspection of Torrent Pharmaceuticals Limited on September 28, 2022 in Indrad. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 28, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Indrad (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4382 | 21 CFR 211.198(b)(2) | Written record of complaint to include findings, follow-up |