MONTVALE, N.J. and TOKYO, April 7, 2020 /PRNewswire/ -- HOYA Corporation and a subsidiary through PENTAX Medical division, Pentax of America, Inc. (collectively, "PENTAX" or "the Company"), 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. PENTAX first disclosed the DOJ investigation in June 2015.
In the DPA, PENTAX acknowledged that it did not timely submit two required MDRs to the U.S. Food and Drug Administration (FDA) for events in the US between July 2013 and December 2014. In addition, PENTAX acknowledged that it failed to send FDA approved IFUs for four types of endoscopes from April 2014 until September 2015. PENTAX agreed to: pay a fine and forfeiture totaling $43 million; undertake new steps to enhance its compliance policies and procedures; and regularly make certain certifications that PENTAX is meeting the requirements of the DPA.
"PENTAX deeply regrets that it did not timely file the MDRs identified in the DPA, as well as the failure to send the approved IFUs to customers. We accept full responsibility for these failures," said David Woods, President of Pentax of America, Inc.
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The DPA does not allege any direct harm to patients as a result of the disclosure failures or failure to send IFUs, and PENTAX acknowledged that it failed to comply with the federal reporting requirements. The DPA does not impact the availability of PENTAX Medical products and services worldwide.
"PENTAX Medical is committed to the highest standards of ethical behavior and we are confident we can fulfill each of the obligations under this DPA to the fullest extent necessary," said Gerry Bottero, Global President, PENTAX Medical.
The full text of the DPA will be available on the PENTAX Medical website.
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. This approach is demonstrated in how we develop clinically relevant endoscopy products, advance cleaning procedures, continuously improve our internal procedures, and empower our customers through expert training and education programs. While we always strive to deliver on our promises, how we achieve those results is equally as important.