FDA Inspection
MiniStim CorpMiniStim Corp – FDA Inspection, Jan 26, 2021
Record Details
This FDA Inspection record concerns MiniStim Corp, with an inspection on January 26, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- MiniStim Corp
- Inspection Date
- January 26, 2021
- Product Type
- Devices
View Company Profile
ID · baf4c1a9-9d5a-443e-9af8-eddfadf806f6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1134979
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 812.46(b)(1)No evaluation of unanticipated adverse effects
- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.150(b)(5)Sponsor progress reports for significant risk study
- 21 CFR 812.140(a)(2)(i)Investigator device accountability inadequate
- 21 CFR 812.150(b)(1)Sponsor evaluation rpt not timely, distributed
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