FDA Inspection
Bradshaw Medical, Inc.Bradshaw Medical, Inc. – FDA Inspection, Feb 28, 2022
Record Details
This FDA Inspection record concerns Bradshaw Medical, Inc., with an inspection on February 28, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Bradshaw Medical, Inc.
- Inspection Date
- February 28, 2022
- Product Type
- Devices
View Company Profile
ID · 31d3e6f8-6f84-4852-bff4-074aaa11ad7a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1163303
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Bradshaw Medical, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 12, 2025 | NAI | Minneapolis District Office | Postmarket Assurance: Medical Devices |
| August 15, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 11, 2016 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Bradshaw Medical, Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.