709696
3CPM Company., INC.- EndoSure, Inc. — FEI 3002900388
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 25, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Sparks Glenco, MD (United States)
Citations
| ID | CFR | Description |
|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14717 | 21 CFR 820.30(g) | Design validation - software validation documentation |
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3204 | 21 CFR 820.40(b) | Change records, content |
| 3696 | 21 CFR 820.100(b) | Documentation |