FDA Inspection 983537 — Biogennix LLC
The FDA completed an inspection of Biogennix LLC on Jul 29, 2016 in Irvine, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- Jul 29, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Irvine, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |