On April 24, 2018, the FDA issued a Form 483 for Zimmer Biomet's Warsaw North Campus, and Zimmer Biomet has now responded.
None of the observations in the Form 483 identified specific issues regarding product performance and the facility continues to manufacture products. "Zimmer Biomet stands behind the safety of the products manufactured at the Warsaw North Campus and is working carefully and expeditiously to address the observations," the company reported.
As reported in The Journal Gazette, Zimmer Biomet said, "misunderstandings may have led to some negative findings." The entire 98-page response refutes some observations but also admitted company representatives provided incomplete information to the FDA, particularly around the sterilization and other processes.
The April inspection was a follow-up from a November 2016 inspection that found quality and manufacturing system issues. At the time, Zimmer was integrating Biomet into the company and followed the inspection instructions within an internal audit and remediation plan, according to the report.
CEO Brian Hanson discussed the inspection during the company's first quarter conference call. "The latest inspection confirmed that quality remediation progress has been made, but we still have work to complete, and we're obviously not satisfied with the current state of our quality system at Warsaw North facility. Unfortunately, there is no quick fix, but our team is working tirelessly to make the necessary improvements," he said.
In its response to the FDA, Zimmer Biomet also mentioned that more work should be done to develop a "robust quality system" at the facility.