FDA Inspection 1175958 — Jubilant Generics Limited
The FDA completed an inspection of Jubilant Generics Limited on Aug 1, 2022 in Roorkee. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Aug 1, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Roorkee (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |
| 4576 | 21 CFR 211.192 | No written record of investigation |