The US Food and Drug Administration (FDA) has issued medical device maker Zimmer Biomet a warning letter over nine quality system issues uncovered at its facility in Montreal.
The warning comes as a result of a four-day inspection of the facility that resulted in an FDA Form 483 last January, during which, FDA says its investigators found issues with the company's procedures for implementing corrective and preventative actions, medical device reporting (MDR), purchasing controls, medical device master records, equipment upkeep (including calibration, inspection, storage and maintenance), quality auditing and record keeping.
However, FDA says it only took into account one of Zimmer's responses to the Form 483 issued after the inspection, as the second response was dated more than a month after the agency's 15-day deadline.
As a result of the warning letter, FDA says it will refuse the approval of any premarket approval applications from Zimmer for Class III devices that could be impacted by the violations cited in the warning letter. However, in an SEC filing in June announcing the receipt of the warning letter, Zimmer said it "has no such applications before the FDA."
Furthermore, Zimmer says it has already "provided detailed responses to the FDA as to its corrective actions," and says it will "continue to work expeditiously to address the issues identified by the FDA."
Zimmer declined to comment on the warning letter to Focus, saying any further updates would be made in subsequent SEC filings.
As a result of the issues, FDA says it considers four of the company's assisted surgery systems – the iAssist Knee System, Zimmer PSI Shoulder System, Zimmer PSI Knee System and Navitrack System – to be adulterated for failing to meet good manufacturing practice (GMP) requirements under the Quality System regulation.
Two of the citations listed in the warning letter had to do with Zimmer's MDR practices.
FDA says Zimmer failed "to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit," and said that eight of the 14 complaints the FDA investigator reviewed from 2015 "did not include an MDR determination" and the company failed "to ensure complaints are evaluated in a timely manner."
In a separate citation, FDA says Zimmer failed to "adequately develop, maintain and implement written MDR procedures." Here, FDA calls on the company to "adjust its MDR procedure accordingly to include a process for submitting MDRs electronically in accordance with the Final Rule for electronic Medical Device Reporting (eMDR)," and instructs the company to contact the agency's Reportability Review Team if it needs further clarification.
According to FDA, Zimmer also failed to notify the agency in a timely manner of at least six product corrections or removals that occurred between 2007 and 2011. In each case, FDA says the company failed to report the correction or removal within the required 10 days.
Furthermore, FDA says it considers Zimmer's iAssist Knee System to be misbranded as the company failed to retain records that explained its justification for not reporting a recall for the device. In this case, FDA says Zimmer must "update its procedures … to ensure that all required information is provided or documented [and] refer to CDRH [Center for Devices and Radiological Health] recall classifications to evaluate future corrections and removals."