A Warsaw-based orthopedic company says misunderstandings led to negative findings at a recent FDA inspection.
Zimmer Biomet issued a 98-page document disputing observations made by the U.S. Food and Drug Administration in April. The visit was a follow-up after quality and manufacturing system issues were found in a November 2016 FDA inspection.
The Journal-Gazette reports inspectors were led to believe some processes were inadequate because Zimmer Biomet representatives did not provide them with complete information. The company says the processes are actually up to federal standards.
Zimmer Biomet officials say “more work is required and needs to be completed to create and sustain the robust quality system we are committed to establishing.”
Production continues at the facility.
The document issued by the company says they do not believe any of the FDA observations will impact product performance, but that they’re committed to ensuring all products and system are in compliance with FDA requirements.
You can read it in its entirety here.