FDA Inspection 1228906 — Biogennix LLC
The FDA completed an inspection of Biogennix LLC on Feb 8, 2024 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
- Feb 8, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Irvine, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |