FDA Inspection 939950 — Datrix LLC
The FDA completed an inspection of Datrix LLC on August 27, 2015 in Escondido, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 27, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Escondido, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |