Zimmer Biomet hit with warning from FDA

(Photo supplied/Zimmer Biomet)

WARSAW, Ind. (WOWO): The Food and Drug Administration issued a warning to a major Warsaw company.

This comes after a recent inspection at Zimmer Biomet’s Montreal production plant, according to the Journal-Gazette.

U.S. inspectors say they saw things at the plant that didn’t comply with “current good manufacturing practice requirements”. The FDA didn’t elaborate on what those violations were in a letter sent to the Security and Exchange Commission in May.

The facility is the home of Zimmer subsidary ORTHOsoft Inc. Zimmer Bioment says they are working to fix the issues the FDA found.

Zimmer Biomet can still make and ship products from the Montreal factory, but applications for certain devices won’t be approved by the FDA until the issues are resolved.


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