FDA Inspection 570605 — Grand Medical
The FDA completed an inspection of Grand Medical on March 12, 2009 in Kansas City, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 12, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Kansas City, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3108 | 21 CFR 820.70(e) | Contamination control, Lack of or inadequate procedures |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3164 | 21 CFR 820.184(d) | Acceptance records |
| 3349 | 21 CFR 820.200(d) | No Service reports |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 4189 | 21 CFR 820.198(a) | General |