Zimmer Biomet Holdings, Inc. today published its response to the Form 483 issued by the U.S. Food and Drug Administration (“FDA”) on April 24, 2018. The Form 483 and the Company’s written response address the inspectional observations related to Zimmer Biomet’s North Campus manufacturing facility in Warsaw, Indiana (“Warsaw North Campus”).
As previously announced on May 16, 2018, none of the observations in the Form 483 identified a specific issue regarding the performance of any particular product, and all products continue to be manufactured by the Warsaw North Campus facility. Zimmer Biomet stands behind the safety of the products manufactured at the Warsaw North Campus and is working carefully and expeditiously to address the observations.
View Zimmer Biomet’s detailed response to the FDA Form 483. In the response, certain limited information has been redacted to the extent necessary to protect Company competitive and proprietary information.