Zimmer Biomet’s Latest Setback: an FDA Warning Letter

Zimmer Biomet received a warning letter from FDA related to its ongoing quality control issues.

FDA sent Zimmer Biomet a warning letter in connection with the agency’s April inspection of the company’s Warsaw North campus.

The company’s quality control problems first cropped up in December 2016 when FDA sent the company a rather long Form 483.  The agency re-inspected the facility in April and made some additional observations, but Zimmer Biomet pushed back on some of those findings.

“During the 2018 FDA inspection, Zimmer Biomet personnel and the FDA investigators disagreed on some technical [corrective action] topics, (or Zimmer Biomet did not provide sufficient context or explanation), as evidenced by some of the FDA-483 observations,” Jeff Gensler, vice president of quality assurance and quality control at Zimmer Biomet, wrote in the company’s 98-page response, which is published on its website.

This week, the Warsaw, IN-based company disclosed in an SEC filing that it recently received a warning letter from FDA related to observations stemming from the April inspection. The company said it is in the process of preparing a written response to the letter.

“While the warning letter acknowledges our quality remediation plan and actions we’ve already taken to address the FDA’s inspectional observations, it notes violations that require additional action or explanation,” the company noted in the regulatory filing.

FDA proposed a meeting with the company to discuss corrections. The warning letter does not restrict production or shipment of products from the Warsaw North Campus facility, nor does it require any products to be recalled, the company noted.

By Amanda Pedersen | MD+DI

Image Credit: Amanda Pedersen / MD+DI


About Peter Coffaro 668 Articles
A growth-driven and strategic executive, Peter Coffaro commands more than 20 years of progressive management success within the orthopedic industry. Recognized by MedReps.com and the World Journal of Orthopedics as one of the top medical sales influencers in the industry; he has 10 years of combined sales management experience and has held positions as a Director, General Manager, Distributor and Vice President. Peter has worked for some of the top orthopedic companies in the world - Zimmer, DePuy and Stryker. He is also the founder of OrthoFeed: a popular blog that covers digital orthopedic news and emerging medical technologies. Peter is a three-time Hall of Fame award winner at Johnson and Johnson and has an extensive background in organizational development, business development, sales management, digital marketing and professional education. Peter holds a B.S. degree in Biology from Northern Illinois University.

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