FDA Inspection 1202017 — Intermed Laboratories Private Limited
The FDA completed an inspection of Intermed Laboratories Private Limited on March 17, 2023 in Chennai. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 17, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chennai (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1504 | 21 CFR 211.122(d) | Labels and labeling stored separately |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2399 | 21 CFR 211.194(a)(2) | Laboratory Test Method Verification |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |