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Having noticed an uptick in medical device recalls and FDA warning letters to medtech companies this year, it seems an appropriate time to look back on a Form 483 from December 2016 that surprised analysts and consultants.

Zimmer Biomet tried to downplay that particular Form 483 by pointing out that FDA often issues this type of form after periodic inspections. While the form itself is indeed common, a 57-page form documenting a manufacturer’s perceived shortcomings was, and still is, anything but ordinary.

Larry Biegelsen, a medtech analyst for Wells Fargo Securities, asked an FDA legal consultant to review the form.

“The bottom line is, this is one of the longest and most serious 483s our consultant has ever seen,” Biegelsen wrote in a report at the time.

The investigators seemed to go to considerable efforts during that 2016 inspection of the company’s legacy Biomet manufacturing site in Warsaw, IN to document violations. Unlike most 483s, this one did not simply provide an example or two of deficiencies, but rather multiple examples.

“It is unusual to be so thorough in documenting a company’s perceived shortcomings,” Biegelsen wrote in his report.

The first observation in that particular Form 483 was identified as a repeat observation and that incident alone accounted for 21 pages of the document.

“Our consultant does not recall ever seeing a 21-page single observation,” Biegelsen wrote. “FDA not only documented that this was a repeat observation, but went to great lengths to document myriad manifestations that the company failed to comply with FDA’s regulations.”

The company insisted that no patient safety concerns had been identified with any of the products manufactured at the site. Zimmer Biomet continued to struggle with quality control and supply chain problems for several more months, however, ultimately resulting in CEO David Dvorak’s resignation in July 2017.

Zimmer Biomet’s transformation began after Bryan Hanson took the helm in December 2017. The turnaround was so impressive that MD+DI editors named Zimmer Biomet the Medtech Company of the Year in 2019. Hanson left Zimmer Biomet last year to lead 3M’s healthcare spinoff. Zimmer Biomet appointed Ivan Tornos to take Hanson’s place.

Article source: MDDI