FDA handed Zimmer Biomet Holdings a warning letter dated May 27, citing GMP non-conformities at the company’s facility in Montreal, Canada.
The firm received a Form 483 in January for similar deficiencies, the company stated in a June 6 SEC filing.
The Canadian facility is the principal location for Zimmer’s wholly owned subsidiary ORTHOsoft.
The warning letter does not restrict production or shipment of the company’s products from the Montreal facility or require the withdrawal of any product from the marketplace nor does it restrict the company from seeking 510(k) clearance of products. It does, however, deny approval of premarket approval applications for Class III devices until the violations have been corrected.
Since the inspection, Zimmer provided responses to the FDA outlining its corrective actions. The company said it can’t estimate how long the resolution process would take.
Last week, Australia’s Therapeutic Goods Administration cautioned healthcare providers that Zimmer’s Trabecular metal knee implant may contain non-sterile implant components that could result in post-operative infection ().
In separate news, Zimmer Biomet announced on June 7 that it would acquire fellow medical device maker LDR Holding for $1.07 billion.
LDR, based in Troyes, France, and Austin, Texas, specializes in implantable spine devices and surgical technologies. Mobi-C CDR is the company’s first and only FDA-approved device to treat both one and two level adjacent damaged cervical discs.