FDA Inspection 1045312 — Micro Labs Limited
The FDA completed an inspection of Micro Labs Limited on March 22, 2018 in Bengaluru. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 22, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bengaluru (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1163 | 21 CFR 211.28(b) | Habits of good sanitation & health |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |