The U.S. Food and Drug Administration routinely inspects medical device facilities to assess quality and regulatory compliance. The FDA has an established framework of procedures for industry oversight in effort to protect the public and the integrity of the broader healthcare system.
On December 21st 2018 Fusion Orthopedics, at their Mesa, Arizona headquarters completed a Level 2 U.S. Food and Drug Administration general inspection. The inspection outcome did not identify any deficiencies and did not result in the issuance of an FDA-483.
Fusion Orthopedics processes and procedures were reviewed. The FDA sampled records to further evaluate compliance with 21 CFR 820. Specific subsystems covered included: Management Responsibility, Production and Process Controls, Design History Files, Complaints, and Corrective and Preventative Actions.
Fusion Orthopedics was pleased with the successful outcome and closure of the inspection by the FDA. As with the December 21st 2018 FDA inspection — a company receives little or no advance notice of an impending FDA onsite inspection. With such a positive outcome for Fusion Orthopedics first FDA inspection it’s a reflection of the high caliber professionals that make every effort to do a job well done. Fusion Orthopedics salutes the performance of its regulatory and quality assurance leadership and all associates who collectively contributed to an effective quality management system.
As a Company that continually strives to improve the health and wellness of the community, they are gratified to receive such a validation.