US FDA Finds Ongoing CAPA Issues In Zimmer Plant Reinspection
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.
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Zimmer Biomet saw increased growth during the second quarter – but the company also confirmed on its recent Q2 earnings call that its quality remediation efforts continue, with fresh FDA observations arising from the agency's most recent inspection of one of Zimmer's Indiana-based manufacturing facilities.
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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