FDA Inspection
New England Research Institutes, Inc.New England Research Institutes, Inc. – FDA Inspection, Jul 13, 2017
Record Details
This FDA Inspection record concerns New England Research Institutes, Inc., with an inspection on July 13, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 47a089bf-b4ea-4594-bd27-a32218f5ba81
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1017765
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 812.150(b)(5)Sponsor progress reports for significant risk study
- 21 CFR 812.25(e)Sponsor"s lack of written monitoring procedures
- 21 CFR 812.25(e)Sponsor's lack of written monitoring procedures
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