Zimmer Biomet cleaned house after FDA inspection at Warsaw plant

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 repla...
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Orthopedics Regulatory/Compliance zimmerbiomet Source Type: news