# FDA 483 - CROSSROADS EXTREMITY SYSTEMS LLC - August 26, 2022

Source: https://www.keypedia.com/records/483/crossroads-extremity-systems-llc/f93f06ad-60c0-4f1f-b483-436329a0a202

> FDA 483 for CROSSROADS EXTREMITY SYSTEMS LLC on August 26, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CROSSROADS EXTREMITY SYSTEMS LLC
- Inspection Date: 2022-08-26
- Product Type: device
- Office Name: New Orleans District Office
- Summary: CROSSROADS EXTREMITY SYSTEMS LLC in Memphis, TN, was inspected from August 22-26, 2022, and received a Form 483 with three observations. The inspection revealed issues with incomplete product validation for the MiniBunion Implant System, a lack of procedures for GUDID labeling requirements, and inadequate documentation and monitoring of environmental controls. These observations indicate deficiencies in the firm's quality system.

## Related Officers

- [Javelle P. Spann](https://www.keypedia.com/people/javelle-p-spann/31a8f7a8-e442-4f5a-b33f-55bfe911e61b)
- [Ebony D. Sanon](https://www.keypedia.com/people/ebony-d-sanon/703dc125-1019-43d1-9598-1bdc92026e2b)

Company: https://www.keypedia.com/companies/crossroads-extremity-systems-llc/dfc0fb7c-36b6-4833-a98b-b0cfaae01714

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea