765250
Adapta Medical, Inc. — FEI 3008772421
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 26, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Colorado Springs, CO (United States)
Citations
| ID | CFR | Description |
|---|
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |