FDA Close Out Chinese Zimmer Biomet Warning Letter
Walter Eisner • Mon, June 19th, 2017
After an FDA inspection of a Biomet knee production facility in Jinhua City, Zhejiang, China, conducted in January 2015, the agency issued the company a Warning Letter. The agency said methods used at the facility were not in conformity with good manufacturing practice requirements.
On May 18, 2017, the agency notified, now Zimmer Biomet Holdings, Inc, that the Warning Letter has been closed out.
The Warning Letter issued on June 3, 2015, cited the example of the company's investigation of how approximately 1,051 of 1,654 “3.5 MM INSERTER CONNECTOR” (Part Nos. 14-441043-01 and 14-44105-00) pieces were manufactured and shipped for final packaging and distribution between November 2010, and March 2013 without meeting minimum required tensile strength. The company’s corporate Regulatory Compliance Director stated that the firm received approximately 45 complaints of tip fracture for the device.
"Your firm initiated CAPA, CA-01097 which states the root cause as '(b)(4)., which lead (b)(4) requirement not transferred into (b)(4)'. However, your firm did not review if other products failed to meet design specifications during design transfer. Additionally, your firm did not investigate how to prevent tip fracture due to torsional overloading," stated the Letter.
The Warning Letter cited four other "failures to establish and maintain procedures," related to production processes.
Zimmer Biomet's President and CEO, David Dvorak, said, "The successful clearance of the Warning Letter related to our Zhejiang, China manufacturing facility is a measure of the progress we have made in our ongoing quality and operational excellence journey. Zimmer Biomet takes seriously its responsibility to support surgeons and their patients, and the Company will continue to take the necessary actions to demonstrate our commitment to quality excellence, patient safety and regulatory compliance."
Warning Letters are instructive for all device makers as they anticipate FDA inspections of their facilities.
They also have consequences as U.S. federal agencies may be advised of the issuance of Warning Letters about devices so they may take the information into account when considering the award of contracts. Additionally, says the FDA, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected.
To study the Biomet Warning Letter, click here.