FDA Inspection
Bradshaw Medical, Inc.Bradshaw Medical, Inc. – FDA Inspection, Aug 15, 2017
Record Details
This FDA Inspection record concerns Bradshaw Medical, Inc., with an inspection on August 15, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · da2a5f81-f71d-4dae-90d3-89ac3a739195
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1021772
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint 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 |
| April 11, 2016 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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