Editor's note: This story has been updated to include statements made during Zimmer Biomet's second-quarter earnings call. A previous version of this story included statements from the company's first-quarter earnings call. MD+DI regrets any confusion this may have caused.
As a follow-up to the company's 2016 inspection, which resulted in a rather long Form 483, FDA re-inspected the facility in April and Zimmer Biomet recently pointed out in its response to the agency that some of the observations during that inspection may be the byproduct of misunderstandings or disagreements between company personnel and FDA investigators.
During Zimmer Biomet's second-quarter earnings call, CEO Bryan Hanson reiterated the importance of patient safety as he talked about the company's ongoing quality remediation plans at its Warsaw North Campus.
Patient safety is the company's first and guiding priority, he said, and execution of its remediation plans is "progressing with the sense of urgency."
"However, fixing these issues in the right way takes time," Hanson said, according to Seeking Alpha transcripts of the call. "I remain confident in the people and the processes we have in place and I can assure you that we will continue to appropriately resource and staff this important work and we will keep the FDA updated on our progress."
He also said that none of FDA's recent observations identified a specific issue regarding the performance of any particular product, and as a result, the facility continues to manufacture its full range of products.
Hanson joined Zimmer Biomet in December, replacing David Dvorak who resigned in July 2017 amid increasing investor frustration. Since joining the company, Hanson has made significant strides toward rebuilding trust within the company as well as between the company and its investors.
"I really do believe we're going to need to see a shift in the culture and the engagement of this organization," he said during a previous call.