Biedermann Motech, Inc.September 16, 2021

FDA 483 - Biedermann Motech, Inc. - September 16, 2021

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Record Details

Biedermann Motech, Inc. in Miami, FL, received a Form FDA 483 following an inspection from September 13-16, 2021. The inspection identified a significant deficiency related to process validation. Specifically, the firm failed to validate software-operated manufacturing steps for Class 2 medical device system instruments, indicating a lapse in quality system requirements.

Company: Biedermann Motech, Inc.
Inspection Date: September 16, 2021
Product Type: Device
Office: Office of Medical Device and Radiological Health Division II
Person: Adaliz Santaliz-Cruz

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ID · 2bd83f83-147a-47c0-9e6d-873a8203ca44