Zimmer Biomet (NYSE:ZBH) today revealed a warning letter it received in late May over non-conformities with good manufacturing practice requirements for its quality system regulation at its Montreal, Quebec facilities.
The letter, which came based on a January inspection of the company’s facilities, restricts the clearance of premarket approval applications for Class III devices which are affected by the quality system regulation deviations. The company said that it has no such applications.
The letter “does not restrict production or shipment” of goods from the Montreal facility, nor does it require any withdrawal of any current products from the market, according to an SEC filing from the company.
Zimmer Biomet said it has “provided detailed responses to the FDA” explaining the corrective actions it took, and added that it believes the warning letter can be “resolved without a material impact on the company’s financial results.”
A definitive response from the FDA could not be guaranteed, and the company warned that until the violations are corrected, it “may be subject to additional regulatory action by the FDA.”
Scottsdale, Ariz.-based Cayenne makes devices for knee and shoulder repair, including the AperFix II, CrossFix II and iFix knee ligament reconstruction and meniscal repair devices and the Quattro device for rotator cuff and labral repairs.