WARSAW — On Aug. 24, a subsidiary of Zimmer Biomet Holdings, Inc. received a warning letter from the U.S. Food and Drug Administration related to observed non-conformities with current good manufacturing practice requirements of the quality system regulation at the North Campus manufacturing facility in Warsaw.

Zimmer Biomet states they are taking the matters identified in the warning letter seriously and are in the process of preparing a written response to the warning letter.

The warning letter is specific to the Warsaw North Campus facility. As previously disclosed, the FDA performed an inspection of the Warsaw North Campus facility in 2016 and issued a Form 483 with inspectional observations at the conclusion of the inspection in late 2016. Also as previously disclosed, the FDA performed a re-inspection of the Warsaw North Campus facility in April and issued a Form 483 with inspectional observations at the conclusion of the re-inspection. While the warning letter acknowledges the quality remediation plan and actions Zimmer Biomet has already taken to address the FDA’s inspectional observations, it notes violations that require additional action or explanation. In the warning letter, the FDA proposes a regulatory meeting with Zimmer Biomet to discuss the proposed corrections.

Zimmer Biomet’s response states they will continue to work expeditiously to address the issues identified by the FDA and intend to respond within fifteen business days to the warning letter. Meanwhile, the warning letter does not restrict production or shipment of products from the Warsaw North Campus facility or require the withdrawal of any product from the marketplace. Nor does it restrict our ability to seek FDA 510(k) clearance of products.