FDA Inspection
Bradshaw Medical, Inc.Bradshaw Medical, Inc. – FDA Inspection, Apr 11, 2016
Record Details
This FDA Inspection record concerns Bradshaw Medical, Inc., with an inspection on April 11, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Bradshaw Medical, Inc.
- Inspection Date
- April 11, 2016
- Product Type
- Devices
View Company Profile
ID · c7bcbbc1-f9dc-4580-9fce-6e9e2e0ad1ae
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 982611
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Bradshaw Medical, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 12, 2025 | NAI | Minneapolis District Office | Postmarket Assurance: Medical Devices |
| February 28, 2022 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 15, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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