FDA WARNING_LETTER - Hoya Corporation - Pentax Life Division

The FDA issued a Warning Letter to Pentax of America, Inc. on March 9, 2018, for failing to comply with a Section 522 postmarket surveillance order (PS150004) issued October 5, 2015. This order required studies on their duodenoscope model ED-3490TK to address reprocessing effectiveness and contamination risks, which could lead to serious adverse health consequences. Pentax failed to commence data collection for the Sampling and Culturing Study within the mandated 15 months. Specifically, by February 2, 2018, only 20 of 85 required Phase 1 samples were collected, missing the May 2017 deadline. Furthermore, the Human Factors Study had zero participants enrolled and had not commenced by February 2, 2018, despite an August 2017 start and January 2018 completion target. These failures constitute a prohibited act under Section 301(q)(1)(C) of the Act, rendering the device misbranded under Section 502(t)(3). The FDA requires a corrective action plan within 15 days, outlining how 50% and 100% of Sampling and Culturing Study samples will be processed by August 31 and December 31, 2018, respectively. For the Human Factors Study, 50% and 100% testing must be completed by May 31 and June 30, 2018. Failure to comply may result in regulatory actions including seizure, injunction, and civil money penalties.