# FDA EIR - Fx Solutions - July 19, 2018

Source: https://www.keypedia.com/records/eir/fx-solutions/a81ec214-f849-4504-a864-e5bfb367f256

> FDA EIR for Fx Solutions on July 19, 2018. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Fx Solutions
- Inspection Date: 2018-07-19
- Product Type: Devices
- Office Name: Office of Regulatory Affairs
- Summary: The FDA conducted an inspection of Fx Solutions, a medical device specification developer located in Viriat, France, from July 16 to July 19, 2018. This inspection was requested by the Office of Medical Device and Radiological Health Operations (OMDRHO) and the Center for Devices and Radiological Health (CDRH) and was performed under compliance program 7382.845. The inspection focused on the firm's management controls, design controls, corrective and preventive actions, and production and process controls.

Fx Solutions specializes in orthopedic devices for shoulder arthroplasty, classified as Class II medical devices. During the inspection, the FDA issued a Form 483 citing inadequate supplier controls. Specifically, the firm's supplier had not validated certain processes for manufacturing shoulder implant cups and orthopedic stem implants. The management of Fx Solutions was cooperative and committed to addressing these issues.

Fx Solutions was founded in 2011 and began shipping products to the United States in 2016. The company operates through contract manufacturers and maintains a final device history record for its products. It has ISO 13485 certification and has established a U.S. subsidiary, FX Shoulder, for distribution.

The inspection report noted a previous recall due to inadequate packaging of certain products, which has since been addressed with improved packaging solutions. Approximately a significant portion of the firm's products are shipped to the United States, with detailed records of shipments maintained.

The FDA requires Fx Solutions to correct the identified supplier control deficiencies to ensure compliance with regulatory standards.

## Related Documents

- [EIR - 2018-07-19](https://www.keypedia.com/records/eir/fx-solutions/ca463271-6c8e-4a10-a852-d7f8096ccecb)
- [EIR - 2018-07-19](https://www.keypedia.com/records/eir/fx-solutions/b8a528aa-098b-43ee-8824-c139b16d2469)
- [EIR - 2018-07-19](https://www.keypedia.com/records/eir/fx-solutions/3d962646-ebf1-40ed-9c78-8b497e600507)

## Related Officers

- [investigator](https://www.keypedia.com/people/stephen-d-eich/a932e816-cbe3-4f1c-84e7-8a81cc8b529e)

Company: https://www.keypedia.com/companies/fx-solutions/5c708ca1-a590-4102-a88e-ba487c15684a

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64