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.

US FDA found potential ongoing problems with corrective actions, test validation and other regulatory issues during an April inspection of Zimmer Biomet Holdings Inc.’s North Campus manufacturing facility in Warsaw, Ind. The company disclosed the inspection results in a May 16 statement.

The agency’s 2016 inspection of the North Campus facility found similar issues that resulted in a 58-page, 14-count FDA Form-483. At the time, Zimmer Biomet said the identified issues predated...

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