# FDA 483 - CrossRoads Extremity Systems, LLC - August 02, 2019

Source: https://www.globalkeysolutions.net/records/483/crossroads-extremity-systems-llc/274752c9-cd30-4272-9b83-6abdf47044cf

> FDA 483 for CrossRoads Extremity Systems, LLC on August 02, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CrossRoads Extremity Systems, LLC
- Inspection Date: 2019-08-02
- Product Type: device
- Office Name: New Orleans District Office
- Summary: CrossRoads Extremity Systems, LLC in Memphis, TN, was inspected by the FDA, resulting in four observations. The inspection revealed deficiencies in documenting justifications for not reporting field corrective actions and inadequate complaint handling for MDR reportable events. Additionally, the firm failed to adequately establish complaint procedures and maintain its device master record.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/amanda-dinaro/6df79979-ad5c-46f5-8917-197f8a0870e0)

Company: https://www.globalkeysolutions.net/companies/crossroads-extremity-systems-llc/62e7b9a4-7703-450f-b2b2-4497ffd71e09

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