Zimmer Biomet (NYSE:ZBH) told the FDA that it cleaned house after the federal safety watchdog’s inspection last year turned up numerous violations at a plant in Warsaw, Ind., replacing 5 operations and quality executives as it sought to bring the facility back into compliance.
The FDA inspected the North Campus location in Warsaw just before Thanksgiving last year and documented numerous violations in a Form 483. The company replied Dec. 21, 2016, with a lengthy account detailing its actions in remediating the problem, noting that company-wide audits put in place after the $14 billion merger of Zimmer and Biomet had already turned up problems at the site.
“Until the Zimmer Biomet merger on June 24, 2015, North Campus had been operating independently and with indications that its quality system was in substantial compliance. Once the merger was completed, the new Zimmer Biomet corporate management team conducted audits, learned of issues through the audits, and promptly initiated corrective actions. Improvements were well underway when FDA started the inspection and will continue with strong support, oversight and resources,” Zimmer Biomet wrote. “As is described in our attached detailed response, in addition to correcting the specific items listed in the FDA-483, we have taken and are continuing to take actions to address systemic issues. Significantly, we took immediate actions to address the quality culture at the site.”
That included replacing the SVP of global operations & logistics; the VP of quality assurance at all of Zimmer-Biomet’s Warsaw sites; the quality assurance director for the North Campus; the compliance director for the Biomet network; and the QA director for post-market surveillance and complaint handling in Warsaw, according to Zimmer-Biomet’s response.
The company’s internal audits, which began in early 2016, “self-identified major compliance-related issues in areas such as design controls, sterile packaging, complaint handling, non-conforming material and [corrective & preventive actions]. A remediation program with approved funding [redacted] was established in July 2016 to address the systemic issues at the North Campus,” the company wrote.
The remediation program at the North Campus was just getting under way when the FDA inspectors came calling, according to the Form 483 response, which runs to 282 pages. The pace of the program accelerated when the inspection turned up more issues, Zimmer Biomet said.
“Rather than wait for the issuance of the FDA-483 to plan and take action, we immediately took steps to correct and improve various aspects of the North Campus quality management system. Immediate containment and investigation actions to date included the initiation of [redacted] product holds , [redacted] health hazard safety evaluations and [redacted] interim control documents. [redacted sentence]. After the FDA inspection concluded, the North Campus remediation efforts were greatly expanded and will be covered under a master CAPA program,” according to the Form 483 response.