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Zimmer Biomet Gets Another FDA Warning Letter for Warsaw Plant

Posted on August 27, 2018

In an SEC filing, Zimmer Biomet announced that they received a warning letter on August 24th from the FDA for "observed non-conformities with current good manufacturing practice requirements of the Quality System regulation" at their North Campus in Warsaw, Indiana.

In 2016, the FDA sent a lengthy Form 483 detailing the quality violations at the plant. The company appeared to have made improvements, but when the FDA performed a re-inspection of the Warsaw North Campus facility in April 2018, they issued another form 483 with inspectional observations at the conclusion of the re-inspection. 

While the warning letter letter acknowledges a quality remediation plan and the actions Zimmer Biomet has taken, the report notes violations that that require additional explanation. In reading between the lines, clearly the FDA was not satisfied with the company's response to their April letter. 

Zimmer Biomet stated in their filing that they will continue to work expeditiously to address the issues identified and they intend to respond to the warning letter within fifteen business days. The FDA also proposed a regulatory meeting to discuss the proposed corrections, which will likely take place subsequent to the submission of their written response to the warning letter. 

The company will continue shipping products from the Warsaw North facility as the warning letter does not restrict Zimmer Biomet from production or shipping products. 

In the filing, Zimmer Biomet said, "We believe that the FDA’s concerns set forth in the Warning Letter can be resolved without a material impact to our financial results. We cannot, however, give any assurances that the FDA will be satisfied with our response to the Warning Letter or as to the expected date of the resolution of the matters included in the Warning Letter. Until the issues cited in the Warning Letter are resolved to the FDA’s satisfaction, the FDA may initiate additional regulatory action without further notice. Any adverse regulatory action, depending on its magnitude, may restrict us from effectively manufacturing, marketing and selling our products and could have a material adverse effect on our business, financial condition and results of operations."