- FDA has issued a warning letter to Zimmer Biomet Holdings for violations of good manufacturing practices at its Warsaw, Indiana, north campus plant, the company disclosed in an SEC filing.
- The warning stems from an inspection of the facility in late 2016 and re-inspection in April 2018, and seeks a meeting to discuss proposed corrections of violations found at the plant.
- The orthopedic device maker said it continues to provide regular updates to FDA on its quality remediation plan and actions it has taken to address the agency’s observations, and it will respond in 15 days to the warning letter.
The former Zimmer Holdings has struggled to integrate Biomet since acquiring its cross-town rival for $13.35 billion in 2015. Manufacturing problems and supply constraints slowed revenue growth, culminating in the resignation of former CEO David Dvorak in July 2017.
Under new CEO Bryan Hanson, a well-regarded veteran medical device executive who joined the company from Medtronic in December, Zimmer Biomet is working to put its problems in the past. Solid second quarter results raised optimism that a turnaround is beginning to take hold, though it is expected to take a few more quarters to gain traction.
The north campus plant in Warsaw is a legacy Biomet facility. On the company’s second quarter earnings call last month, Hanson said execution of the quality remediation plan for the facility was progressing with a sense of urgency, but fixing the issues in the right way would take time.
“We will continue to work expeditiously to address the issues identified by the FDA,” the company said in its SEC filing responding to the warning letter.
The FDA letter does not restrict production or shipment of products from the north campus facility or require the withdrawal of any devices from the market, Zimmer noted. It does not prevent the company from seeking FDA 510(k) clearance of products.
But FDA will not grant premarket approval applications for Class III devices until the quality rule violations are corrected. The company said it had no such applications before the FDA.
Zimmer Biomet said it expects to resolve the issues identified in the warning letter without a material impact to its financial results.