FDA Inspection 1273614 — Microtrol Sterilisation Services Pvt. Ltd.
The FDA completed an inspection of Microtrol Sterilisation Services Pvt. Ltd. on Jun 11, 2025 in Bangalore. 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
- Jun 11, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bangalore (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |