1193127
Amsino Healthcare (USA) Inc — FEI 1417519
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 19, 2022
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Vernon Hills, IL (United States)
Citations
| ID | CFR | Description |
|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4409 | 21 CFR 211.194(a)(4) | Data secured in course of each test |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |