# FDA 483 - Spinal Resources, Inc. - February 27, 2020

Source: https://www.keypedia.com/records/483/spinal-resources-inc/1e9feda0-5fb6-47d9-af88-b001fe6d89d1

> FDA 483 for Spinal Resources, Inc. on February 27, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Spinal Resources, Inc.
- Inspection Date: 2020-02-27
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Spinal Resources, Inc., a medical device specification developer in Fort Lauderdale, FL, was cited with four observations during an FDA inspection. The firm failed to adequately establish procedures for design review, design verification, and design transfer, particularly concerning a T-25 Torx configuration design change. Additionally, the inspection revealed deficiencies in their corrective and preventive action procedures, specifically regarding thorough failure investigations and verification of effectiveness.

## Related Documents

- [483 - 2023-05-01](https://www.keypedia.com/records/483/spinal-resources-inc/b5cabb34-06d0-44a8-bf11-17b315750765)

## Related Officers

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

Company: https://www.keypedia.com/companies/spinal-resources-inc/a6bc95f7-63ca-4ce6-bc11-784efa83bada

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