FDA Inspection 848405 — Amsino Healthcare (USA) Inc
The FDA completed an inspection of Amsino Healthcare (USA) Inc on Aug 30, 2013 in Vernon Hills, IL. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 30, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Vernon Hills, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3682 | 21 CFR 820.70(d) | Implementing Personnel Procedures, Health, Cleanliness. |