# FDA 483 - Structure Medical, LLC - March 03, 2017

Source: https://www.globalkeysolutions.net/records/483/structure-medical-llc/81fa3af0-78c7-4259-8964-2aebe1da7d8a

> FDA 483 for Structure Medical, LLC on March 03, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Structure Medical, LLC
- Inspection Date: 2017-03-03
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Structure Medical, LLC, a medical device contract manufacturer in Naples, FL, was cited for significant deficiencies in its quality system. The inspection revealed inadequate procedures for corrective and preventive actions, rework documentation, acceptance activities, and internal quality audits. These issues indicate a lack of robust controls to ensure product quality and compliance with regulatory requirements.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/structure-medical-llc/a7ad586b-233a-4fb5-8697-ef435b73ed43

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