1016612
EDM3 LLC — FEI 1000526105
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 30, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Jacksonville, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |