The FDA inspected the North Campus location in Warsaw just before Thanksgiving 2016, documenting numerous violations in a Form 483. The company’s lengthy reply that December detailed its actions in remediating the problem, noting that company-wide audits put in place after the $14 billion merger of Zimmer and Biomet had already turned up problems at the site. Zimmer said it cleaned house after the inspection, replacing five operations and quality executives as it sought to bring the facility back into compliance.
But a re-inspection last April resulted in another Form 483 and Zimmer’s response evidently wasn’t enough to mollify the federal safety watchdog. Zimmer said it received a warning letter August 24 that detailed “observed non-conformities with current good manufacturing practice requirements of the quality system regulation” at the North Campus facility.
“We take the matters identified in the warning letter seriously and are in the process of preparing a written response” within 15 business days, the company said today, noting its plans to accept the FDA’s proposal for a regulatory meeting.
The warning letter doesn’t bar the company from selling any devices made at the North Campus plant, it 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,” Zimmer Biomet said.
ZBH shares were down 1.5% to $123.50 apiece today in pre-market trading.