Biedermann Motech, Inc.November 23, 2022

FDA 483 - Biedermann Motech, Inc. - November 23, 2022

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Record Details

Biedermann Motech, Inc., a medical device specification developer in Miami, FL, was cited with two observations during an FDA inspection. The firm failed to adequately establish and implement procedures for controlling non-conforming products, specifically regarding documentation for an open nonconformance report. Additionally, the company's complaint handling system was found to be deficient, lacking required second-person reviews for multiple complaint records.

Company: Biedermann Motech, Inc.
Inspection Date: November 23, 2022
Product Type: Device
Office: Office of Medical Device and Radiological Health Division II
Person: Stanley B. Eugene (investigator)

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ID · 099faa0e-061f-4080-b085-a9cc461bd18a