FDA Inspection 1107131 — Shriram Institute For Industrial Research
The FDA completed an inspection of Shriram Institute For Industrial Research on Oct 22, 2019 in Delhi. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Oct 22, 2019
- Fiscal Year
- 2020
- 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 |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 2399 | 21 CFR 211.194(a)(2) | Laboratory Test Method Verification |
| 2400 | 21 CFR 211.194(a)(3) | Statement of Sample Weights and Measures |
| 4407 | 21 CFR 211.194(a)(2) | Reference and method not stated |
| 4409 | 21 CFR 211.194(a)(4) | Data secured in course of each test |