859740
Gold Standard Diagnostics — FEI 3007208259
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 20, 2013
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Davis, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |