FDA Inspection 1067389 — Advanced Bionics, LLC
The FDA completed an inspection of Advanced Bionics, LLC on September 28, 2018 in Valencia, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 28, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Valencia, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |