FDA Inspection 1045673 — Microtrol Sterilisation Services Pvt. Ltd.
The FDA completed an inspection of Microtrol Sterilisation Services Pvt. Ltd. on March 21, 2018 in Bangalore. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 21, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bangalore (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1976 | 21 CFR 211.182 | Specific information required in individual logs |