684786
MAC Medical Inc. — FEI 3006342679
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 8, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Millstadt, IL (United States)
Citations
| ID | CFR | Description |
|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 3837 | 21 CFR 820.25(b) | Training records |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |