Zimmer Biomet (NYSE:ZBH) said today that the FDA closed out a 2015 warning letter over problems at a subsidiary’s plant in China.
The June 3, 2015 letter flagged 5 violations found during inspections of the Zhejiang Biomet Medical Products plant in Jinhua City, Zhejiang, following inspections of January of that year.
The federal safety watchdog closed the matter May 8.
“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,” president & CEO David Dvorak said in prepared remarks. “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.”
A year ago Warsaw, Ind.-based Zimmer Biomet revealed another warning letter it received in late May over issues with good manufacturing practice requirements for quality systems at its Montreal facilities.
