FDA Inspection 684786 — MAC Medical Inc.
The FDA completed an inspection of MAC Medical Inc. on October 8, 2010 in Millstadt, IL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- October 8, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: 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 |