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Medical Devices / Inspections and Audits

FDA Warns Zimmer Biomet for Quality Violations

Sept. 5, 2018
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Zimmer Biomet’s Warsaw, Indiana orthopedic implant manufacturing facility drew a warning from the FDA for quality violations dating back to 2016 after an April inspection revealed ongoing problems.

In its Aug. 24 warning letter, the FDA noted the facility implemented “numerous interim controls” in response to the 2016 inspection findings but that the spring inspection revealed “continuing, significant violations.”

The agency was not fully satisfied with the company’s response to the Form 483 report issued on April 24 or with a July 31 status update.

Three separate CAPAs reviewed during the April inspection revealed that the firm did not demonstrate that the CAPAs were effective in ensuring that the distributed devices met finished product specifications.

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