Updated: FDA Warns Zimmer Biomet’s Indiana Plant
Zimmer Biomet announced Friday via an SEC filing that it received a warning letter related to observed non-conformities with current good manufacturing practice (CGMP) requirements of the quality system regulation at its manufacturing facility in Warsaw, Indiana.
The warning letter follows a lengthy Form 483 for the facility in May and another 483 dating back to 2016, though the company said it believes that FDA’s concerns “can be resolved without a material impact to our financial results.”
The facility has had a history of inspectional issues, though Zimmer said it has provided written responses “detailing corrective actions underway to address the FDA’s observations and have provided, and will continue to provide, regular updates to the FDA regarding our quality remediation plan at the Warsaw North Campus.”
The letter, according to Zimmer, proposes a regulatory meeting to discuss the proposed corrections and notes that requests for Certificates to Foreign Governments will not be granted until the violations have been corrected. In addition, premarket approval applications for Class III devices to which the quality system regulation violations are reasonably related will not be approved until the violations have been corrected, though Zimmer notes it does not have any such applications before FDA.
But the warning letter does not restrict production or shipment of products from the facility or require the withdrawal of any product from the marketplace, nor does it restrict Zimmer’s ability to seek FDA 510(k) clearance of products.
“We take the matters identified in the Warning Letter seriously and are in the process of preparing a written response to the Warning Letter,” Zimmer said. “We expect that the proposed Regulatory Meeting will take place subsequent to the submission of our written response to the Warning Letter.”
Warning Letter
According to the warning letter, which was posted to FDA's site early Tuesday but then taken down, Zimmer was cited for six violations, including failing to establish and maintain procedures for verifying or validating a corrective and preventive action.
"During the inspection, review of three separate CAPA’s revealed that your firm has not been able to demonstrate that the corrective or preventive actions taken by your firm are effective in ensuring that devices being distributed meet all finished product specifications," the warning letter says.
Zimmer was also cited for failing to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance.
"During the inspection. we observed five separate operations in which employees on the production line were not following production procedures adequately," FDA said.
SEC Filing,
Article updated on 8/28 with info on the warning letter.