FDA Inspection 1134979 — MiniStim Corp
The FDA completed an inspection of MiniStim Corp on January 26, 2021 in Boca Raton, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 26, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Boca Raton, FL (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2952 | 21 CFR 812.46(b)(1) | No evaluation of unanticipated adverse effects |
| 2981 | 21 CFR 812.140(a)(2)(i) | Investigator device accountability inadequate |
| 3038 | 21 CFR 812.150(b)(1) | Sponsor evaluation rpt not timely, distributed |
| 3049 | 21 CFR 812.150(b)(5) | Sponsor progress reports for significant risk study |