# FDA 483 - AMS Diagnostics, LLC - January 21, 2020

Source: https://www.globalkeysolutions.net/records/483/ams-diagnostics-llc/881e97e6-fed7-4086-aca6-b7b9ee2ae969

> FDA 483 for AMS Diagnostics, LLC on January 21, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AMS Diagnostics, LLC
- Inspection Date: 2020-01-21
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of AMS Diagnostics, LLC in Weston, FL, a medical device manufacturer, revealed significant deficiencies in its quality management system. The firm failed to adequately establish and maintain its organizational structure, appoint a management representative, and implement proper management review procedures. Additionally, the inspection found issues with the firm's internal audit program and corrective and preventive action processes, indicating a systemic breakdown in quality oversight.

## Related Officers

- [Dianiris C. Ayala](https://www.globalkeysolutions.net/people/dianiris-c-ayala/ba6c5538-201b-4c9a-8f23-e160db6868e6)

Company: https://www.globalkeysolutions.net/companies/ams-diagnostics-llc/b7d349b6-c445-412f-9d3b-10ff26728a04

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