FDA Inspection 1244163 — Edward Food Research & Analysis Centre Limited
The FDA completed an inspection of Edward Food Research & Analysis Centre Limited on Jul 19, 2024 in Kolkata. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 19, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Kolkata (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |