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

Source: https://www.keypedia.com/records/483/biedermann-motech-inc/2bd83f83-147a-47c0-9e6d-873a8203ca44

> FDA 483 for Biedermann Motech, Inc. on September 16, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biedermann Motech, Inc.
- Inspection Date: 2021-09-16
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

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## Related Officers

- [Adaliz Santaliz-Cruz](https://www.keypedia.com/people/adaliz-santaliz-cruz/47bd4220-e6cc-4582-a4f5-bd4337f92622)

Company: https://www.keypedia.com/companies/biedermann-motech-inc/898251a1-feef-4292-a808-775af93f8cc7

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6