1100751
Microcare Medical — FEI 1720499
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 29, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Commerce City, CO (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |