FDA Inspection 1231364 — Shriram Institute for Industrial Research
The FDA completed an inspection of Shriram Institute for Industrial Research on February 29, 2024 in Delhi. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 29, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Delhi (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |