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FDA Inspection
•Bradshaw Medical, Inc.•September 12, 2025

Bradshaw Medical, Inc. – FDA Inspection, Sep 12, 2025

Record Details

This FDA Inspection record concerns Bradshaw Medical, Inc., with an inspection on September 12, 2025, issued by the Minneapolis District Office, covering medical devices & rad health.

Company
Bradshaw Medical, Inc.
Inspection Date
September 12, 2025
Product Type
Medical Devices & Rad Health
Office
Minneapolis District Office
Person
  • Shuana H. Xiong (Investigator)
View Company Profile

ID · 7dce6122-c433-4bca-a832-f0bd63ba1843

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1281560
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Medical Devices
Outcome
Form 483 issued, view the record

FDA Citations

3
  1. 21 CFR 820.100(a)Lack of or inadequate procedures
  2. 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
  3. 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Bradshaw Medical, Inc.

3
DateClassificationOfficeProject area
February 28, 2022VAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
August 15, 2017VAICenter for Devices and Radiological HealthCompliance: Devices
April 11, 2016VAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
Other documents for Bradshaw Medical, Inc.
  • FDA Inspection 1163303 - 2022-02-28
  • FDA Inspection 1021772 - 2017-08-15
  • FDA Inspection 982611 - 2016-04-11

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