FDA Inspection 1152295 — Amsino Healthcare (USA) Inc
The FDA completed an inspection of Amsino Healthcare (USA) Inc on September 20, 2021 in Vernon Hills, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 20, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Vernon Hills, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1224 | 21 CFR 211.67(b)(6) | Cleaning SOP/inspection |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1976 | 21 CFR 211.182 | Specific information required in individual logs |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3665 | 21 CFR 820.20(b)(3) | Management representative |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |