On June 25, 2018 Zimmer Biomet Holdings, Inc. responded to findings of an FDA Form 483 report after an April agency inspection of its troubled Warsaw, Indiana North Campus plant.
FDA inspectors reportedly believed certain sterilization and other processes were inadequate. However, the company said the processes were up to federal standards and that the company’s own representatives may have provided incomplete information to agency inspectors.
A specific example is on page 4 of the company’s 98-page response, the company writes:
“… [the company] did not implement corrective actions sufficient to prevent the recurrence of bacterial endotoxin test (BET) excursions and questions Zimmer Biomet’s decision not to conduct a recall related to a BET failure.”
The company says it believes the investigators, “misunderstood or lacked important context about the information reviewed by Zimmer Biomet’s Global Recall Committee (GRC) when it decided that no field action was required. Specifically, the observation claims that a Zimmer Biomet study report did not provide objective evidence sufficient to support the no-field-action decision.”
However, the company says the study “was not the sole, or even primary, source of data” relied upon by the GRC.
The most recent FDA inspection was a follow-up visit after a November 2016 FDA inspection identified quality and manufacturing systems issues that needed to be addressed after Zimmer acquired Biomet, Inc.
The regulatory problems resulted in inventory shortages which hurt company revenues and ended the tenure of the CEO who engineered the Biomet acquisition. Some Wall Street analysts, such as Argus analyst David Toung, wrote, “We are concerned that customers, who are typically orthopedic surgeons and the hospitals they work at, are feeling less confidence in Zimmer Biomet’s assurances to restore full inventory and are switching to other orthopedic suppliers.”
In the June 25 response, the company said that while production at the North Campus facility is continuing, “more work is required and needs to be completed to create and sustain the robust quality system we are committed to establishing.”
“Zimmer Biomet does not believe that any of the April 2018 FED-483 observations identifies a specific issue or trend impacting the performance of any particular product released to the market that was not already addressed by the Zimmer Biomet (quality management system)…,” the document states.
The paragraph continues: “Zimmer Biomet is committed to taking all actions necessary to ensure that its products and systems are in compliance with all FDA requirements, and the company is steadfast in its determination that its products must be safe and effective.”
To read the company’s 98-page response, click here.
