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

Source: https://www.keypedia.com/records/483/biedermann-motech-inc/099faa0e-061f-4080-b085-a9cc461bd18a

> FDA 483 for Biedermann Motech, Inc. on November 23, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biedermann Motech, Inc.
- Inspection Date: 2022-11-23
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

## Related Documents

- [483 - 2019-10-15](https://www.keypedia.com/records/483/biedermann-motech-inc/1bc5f1e6-d9cd-4f3d-b66d-865e31acbd6d)
- [483 - 2021-09-16](https://www.keypedia.com/records/483/biedermann-motech-inc/2bd83f83-147a-47c0-9e6d-873a8203ca44)
- [483 - 2022-11-23](https://www.keypedia.com/records/483/biedermann-motech-inc/f8be100a-f198-4265-bc08-f1166ab84c1f)

## Related Officers

- [investigator](https://www.keypedia.com/people/stanley-b-eugene/4708f43e-0592-4c24-b276-d9f9092788a3)

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