Biedermann Motech, Inc.October 15, 2019

FDA 483 - Biedermann Motech, Inc. - October 15, 2019

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Record Details

Biedermann Motech, Inc. in Miami, FL, a specification developer and contract manufacturer, received a Form 483 for significant quality system deficiencies. The inspection revealed multiple failures in validation processes, including cleaning, manufacturing, design, and software for medical device instruments. Additionally, issues were identified with incoming product acceptance and supplier monitoring documentation.

Company: Biedermann Motech, Inc.
Inspection Date: October 15, 2019
Product Type: Device
Office: Office of Medical Device and Radiological Health Division II
Person: Ashley A. Mutawakkil

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ID · 1bc5f1e6-d9cd-4f3d-b66d-865e31acbd6d