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

Source: https://www.globalkeysolutions.net/records/483/biedermann-motech-inc/1bc5f1e6-d9cd-4f3d-b66d-865e31acbd6d

> FDA 483 for Biedermann Motech, Inc. on October 15, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biedermann Motech, Inc.
- Inspection Date: 2019-10-15
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

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## Related Officers

- [Ashley A. Mutawakkil](https://www.globalkeysolutions.net/people/ashley-a-mutawakkil/512be391-fd96-451c-9569-98e43cfba9db)

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

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