FDA Inspection 712075 — Berkeley Advanced Biomaterials, LLC
The FDA completed an inspection of Berkeley Advanced Biomaterials, LLC on Feb 17, 2011 in Berkeley, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Feb 17, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Berkeley, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |