1034866
Catachem, Inc. — FEI 2434178
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- December 14, 2017
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Oxford, CT (United States)
Citations
| ID | CFR | Description |
|---|
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |