# FDA 483 - FCM SMART CENTER GROUP - February 25, 2020

Source: https://www.keypedia.com/records/483/fcm-smart-center-group/3075195a-75bc-46fb-893a-5c699071f290

> FDA 483 for FCM SMART CENTER GROUP on February 25, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FCM SMART CENTER GROUP
- Inspection Date: 2020-02-25
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Baymar Solutions, LLC, a contract manufacturer in Tampa, FL, was inspected by the FDA, revealing significant deficiencies in their quality system. The inspection cited inadequate corrective and preventive action procedures, conflicts of interest in quality audits, and a lack of documented personnel training for audit activities. These findings indicate a need for substantial improvements in their quality management processes.

## Related Officers

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

Company: https://www.keypedia.com/companies/fcm-smart-center-group/0cb7e27b-041e-4660-bfb3-6f3772d5806a

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