Compliance & Ethics
April 7, 2020
PENTAX Medical’s parent company, HOYA Corporation, and one of its subsidiaries, today finalized a Deferred Prosecution Agreement (DPA) with the U.S. Department of Justice (DOJ) on issues related to the timely filing of Medical Device Reports (MDRs) for PENTAX Medical’s duodenoscopes and providing updated Instructions for Use (IFUs) for several PENTAX Medical products. The issues underlying the investigation were first disclosed by PENTAX Medical in February 2015. The Deferred Prosecution Agreement can be found at the bottom of this page.
The DPA is a result of an investigation that began in 2015 related to our duodenoscope products and those of two other manufacturers. In order to resolve the investigations and be able to move forward with our business, we have decided to enter into the DPA, which addresses our failure to timely file two Medical Device Reports (MDRs) with the Food and Drug Administration and the failure to ship approved instructions for use in four types of endoscopes. The key elements of the DPA are an agreement to:
- Pay a criminal fine and forfeiture of $43 million
- Enact enhanced compliance measures
- Regularly make certain certifications
- Undertake measures addressing training and business conduct
- Audit and regularly review our practices regarding MDRs and instructions for use
At PENTAX Medical, we have an unwavering commitment to our customers and their patients to provide safe, high-quality products and services that offer true value. To that end, we develop products and services that enable our customers to improve clinical outcomes, reduce the cost of healthcare, and enhance the experience they deliver to patients. While we always strive to deliver on our promises, how we achieve those results is equally as important.
We are committed to the highest standards of ethical behavior, and we equally committed to fulfilling each of the obligations under this DPA to the fullest extent necessary.
Sincerely,
David Woods
President and CEO, Pentax of America Inc.
Gerry Bottero
Global President, PENTAX Medical
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