Zimmer: Surprised By Biomet Quality Problems, But Responded Before FDA Arrived
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.
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US FDA has released a six-violation warning letter sent to a Zimmer Biomet facility in Warsaw, Ind. The company had already acknowledged that the letter was a possibility.
A follow-up inspection evaluating Zimmer Biomet’s progress in remediating issues documented in a 2016 FDA Form-483 uncovered 11 observations, eight of them repeats.
While Zimmer Biomet's search goes on for a new CEO to replace David Dvorak, who stood down in mid-summer, analysts are pressing for a replacement in short order to put stability back into the global No.2 orthopedic device group, which has sales headwinds and ongoing implant production issues at North Campus, Warsaw, to contend with.