# FDA 483 - Spinal Resources, Inc. - May 01, 2023

Source: https://www.globalkeysolutions.net/records/483/spinal-resources-inc/b5cabb34-06d0-44a8-bf11-17b315750765

> FDA 483 for Spinal Resources, Inc. on May 01, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Spinal Resources, Inc.
- Inspection Date: 2023-05-01
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Spinal Resources, Inc. in Fort Lauderdale, FL, a specification developer of orthopedic medical devices, received a Form FDA 483 with seven observations. The inspection revealed significant deficiencies in their quality system, including failures in medical device reporting, acceptance activities, control of nonconforming product, complaint handling, management reviews, internal quality audits, and supplier controls. These issues indicate a broad lack of adherence to established procedures and regulatory requirements for medical device manufacturing.

## Related Documents

- [483 - 2020-02-27](https://www.globalkeysolutions.net/records/483/spinal-resources-inc/1e9feda0-5fb6-47d9-af88-b001fe6d89d1)

## Related Officers

- [Alex J. Wild](https://www.globalkeysolutions.net/people/alex-j-wild/bb1b66b3-19b9-480e-af0b-f06f8de0d930)
- [Ebony D. Sanon](https://www.globalkeysolutions.net/people/ebony-d-sanon/703dc125-1019-43d1-9598-1bdc92026e2b)

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

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