717119
Immco Diagnostics, Inc. — FEI 1315336
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 22, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Buffalo, NY (United States)
Citations
| ID | CFR | Description |
|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |