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Zimmer: Surprised By Biomet Quality Problems, But Responded Before FDA Arrived

 
• By Elizabeth Orr

Zimmer Biomet's response to a US FDA Form-483 says the firm was unaware of the quality systems woes at the targeted Biomet Warsaw, Ind., plant before its 2015 acquisition of the company. But, it emphasized, comprehensive fixes were in the works even before the 2016 agency inspection that generated more than a dozen substantive observations took place.

Zimmer Biomet Holdings Inc. acknowledged major compliance weaknesses in pre-merger Biomet's quality control processes that Zimmer only learned about after its 2015 $13bn acquisition of the firm. But the orthopedic giant said it was well into fixing the issues before US FDA investigators came knocking in the fall of 2016.

Those details came out in a 282-page response letter from Zimmer Biomet to an unfavorable, late-2016 agency inspection....

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