FDA Inspection 1015090 — Newport Brain Research Laboratories, Inc.
The FDA completed an inspection of Newport Brain Research Laboratories, Inc. on Jun 14, 2017 in Newport Beach, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 14, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Newport Beach, CA (United States)
Additional details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 14516 | 21 CFR 812.25(e) | Sponsor's lack of written monitoring procedures |