FDA Inspection
Blue Belt Technologies, IncBlue Belt Technologies, Inc – FDA Inspection, Feb 6, 2020
Record Details
This FDA Inspection record concerns Blue Belt Technologies, Inc, with an inspection on February 6, 2020, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Blue Belt Technologies, Inc
- Inspection Date
- February 6, 2020
- Product Type
- Devices
View Company Profile
ID · 79d53896-a36a-4276-a781-16e0748282df
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1117026
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Blue Belt Technologies, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 24, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 6, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Blue Belt Technologies, Inc
- FDA Inspection 962792 - 2016-02-24
- FDA Inspection 817488 - 2013-02-06
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