# FDA 483 - Medas, Inc. - July 25, 2022

Source: https://www.globalkeysolutions.net/records/483/medas-inc/b5152cef-7c1e-46a9-aa39-074b7fff227a

> FDA 483 for Medas, Inc. on July 25, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medas, Inc.
- Inspection Date: 2022-07-25
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Medas Inc, a medical device repackager/relabeler in Miami, FL, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, control of storage areas, equipment calibration, and medical device reporting. These issues indicate a lack of robust quality management practices.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/medas-inc/83dcb647-e636-4d5e-a575-2e29486bd2dc

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