1017381
Amsino Healthcare (USA) Inc — FEI 1417519
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 10, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Vernon Hills, IL (United States)
Citations
| ID | CFR | Description |
|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3548 | 21 CFR 211.46(c) | Air filtration system lacking in production area |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 4382 | 21 CFR 211.198(b)(2) | Written record of complaint to include findings, follow-up |