Zimmer Biomet has said it will respond to a warning letter from the Food and Drug Administration over violations found in a 2016 inspection of its northern campus at the old Biomet headquarters.
Zimmer Biomet formally replied to the letter, saying it had taken action. But in a re-inspection last year, the FDA indicated it was still not satisfied with the changes, according to a report by MassDevice.com.
Zimmer said it received a warning letter Aug. 24 that detailed “observed non-conformities with current good manufacturing practice requirements of the quality system regulation” at the North Campus facility, according to a report by MassDevice.com.
The website quotes Zimmer Biomet: “We take the matters identified in the warning letter seriously and are in the process of preparing a written response” within 15 business days, noting its plans to accept the FDA’s proposal for a regulatory meeting.
The warning letter doesn’t bar the company from selling any devices made at the North Campus plant, it said.
