1275275
JAS Diagnostics, Inc./Drew Scientific, Inc. — FEI 3003071743
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 12, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Miami Lakes, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3837 | 21 CFR 820.25(b) | Training records |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |