818543
Poiesis Medical, LLC — FEI 3009425008
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 12, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Jupiter, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |