Zimmer Biomet’s Latest Setback: an FDA Warning Letter

August 28, 2018 FDA, Medical Devices, Orthopedics, Regulatory, Zimmer Biomet

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

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About Peter Coffaro 493 Articles

A growth-driven and strategic executive, Peter Coffaro commands more than 20 years of progressive management success within the medical device industry. As a District Sales Manager for Stryker Orthopaedics, Peter was responsible for managing and directing a regional sales force to achieve sales and profit goals within the Rocky Mountain region. Previously, he was the Director of Sales & Marketing for Amp Orthopedics. In this role, Peter was responsible for planning, developing, and leading all sales and marketing initiatives. Peter is a former orthopedic distributor in the Pacific Northwest. He has also worked with DePuy Orthopaedics as well as Zimmer, and held positions in sales, sales training, and sales management. Peter has an extensive background in organizational development, business development, sales management, negotiating and P&L management. Peter holds a B.S. degree in Biology from Northern Illinois University.