FDA EIR - Fx Solutions - July 19, 2018

The FDA conducted an inspection of Fx Solutions, a medical device specification developer based in Viriat, France, from July 16 to July 19, 2018. This inspection, requested by the Office of Medical Device and Radiological Health Operations (OMDRHO) and the Center for Devices and Radiological Health (CDRH), was a QSIT Level II inspection focusing on the firm's management, design, corrective and preventive actions, and production controls. Fx Solutions specializes in orthopedic devices for shoulder arthroplasty, classified as Class II medical devices.

The inspection revealed significant issues with supplier controls. Specifically, a supplier had not validated processes for manufacturing shoulder implant components, leading to the issuance of an FDA Form 483. The firm's management was cooperative and committed to addressing these deficiencies.

Fx Solutions, founded in 2011, markets its products primarily in the United States through its subsidiary, FX Shoulder. The company experienced a recall due to inadequate packaging of certain sterile products, which was attributed to transportation issues. They have since improved their packaging processes.

The regulatory framework guiding this inspection includes compliance program 7382.845, which outlines the requirements for medical device manufacturers. Fx Solutions is required to validate its supplier processes to ensure compliance with FDA standards and to prevent future issues.

The inspection was led by Stephen D. Eich, with Jean-Marie Daudet, the Director General of Fx Solutions, serving as the primary contact. The firm has been ISO 13485 certified and continues to operate under the ownership of Ekkio of Paris, France.