FDA Inspection 1017765 — New England Research Institutes, Inc.
The FDA completed an inspection of New England Research Institutes, Inc. on July 13, 2017 in Watertown, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 13, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Watertown, MA (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 |
| 3049 | 21 CFR 812.150(b)(5) | Sponsor progress reports for significant risk study |