# FDA 483 - MPM Medical LLC - December 12, 2019

Source: https://www.keypedia.com/records/483/mpm-medical-llc/16bb582e-dada-4e40-be94-8b56e9d1e790

> FDA 483 for MPM Medical LLC on December 12, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MPM Medical LLC
- Inspection Date: 2019-12-12
- Product Type: device
- Office Name: Dallas District Office
- Summary: MFM MEDICAL LLC, a medical device manufacturer in Mesquite, TX, was inspected by the FDA from December 9-12, 2019. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding complaint handling procedures and the complete absence of a quality audit program. These issues indicate a lack of adherence to established Quality System Regulations.

## Related Documents

- [483 - 2023-01-05](https://www.keypedia.com/records/483/mpm-medical-llc/b197a450-9788-4d6c-b858-c25f7b9adc4f)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/roy-baby/69a18ef5-167c-41eb-a57e-3d138a0820c2)
- [Creighton T. Tuzon](https://www.keypedia.com/people/creighton-t-tuzon/be0d09c0-59f4-48c3-9e3d-a1ceb2587e3e)

Company: https://www.keypedia.com/companies/mpm-medical-llc/883e1d74-fe52-4abd-bf22-cb9336aa52fd

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9