Inspections, Compliance, Enforcement, and Criminal Investigations

Hoya Corporation - Pentax Life Division 3/9/18



Black HHS-Blue FDA Logo



10903 New Hampshire Avenue
Silver Spring, MD 20993 


March 9, 2018 
David G. Woods
President and CEO
Pentax of America, Inc.  
3 Paragon Drive
Montvale, New Jersey 07645
Dear Mr. Woods:
The United States Food and Drug Administration (FDA) is issuing this Warning Letter to inform you of Pentax of America, Inc.’s failure to comply with requirements under section 522 of the Federal Food, Drug and Cosmetic Act (the Act) (21 U.S.C. § 360l), and Title 21 of the Code of Federal Regulations (CFR) Part 822. On October 5, 2015, FDA ordered your firm to conduct postmarket surveillance on duodenoscope model ED-3490TK.
FDA issued a postmarket surveillance order (PS150004) (“522 Order”) because failure of these devices would be reasonably likely to cause infection and possibly death in patients undergoing endoscopic retrograde cholangiopancreatography procedures, which would meet the definition of “serious adverse health consequences” at 21 C.F.R. § 822.3(k). Specifically, your firm was ordered to conduct postmarket surveillance to address three questions regarding how duodenoscopes are reprocessed in real-world settings, as follows:
1.    Are the user materials that are included in your firm’s duodenoscope labeling and instructions for use sufficient to ensure user adherence to your firm’s reprocessing instructions? (Note: User materials include user manuals, brochures, and quick reference guides from the manufacturer that are provided to the reprocessing staff) (Human Factor Study)
2.    After use of your firm’s labeled reprocessing instructions, what percentage of clinically used duodenoscopes remain contaminated with viable microorganisms? (Sampling and Culturing Study)
3.    For devices that remain contaminated after use of your firm’s labeled reprocessing instructions, what factors contribute to microbial contamination and what steps are necessary to adequately decontaminate the device? (Sampling and Culturing Study)
FDA has communicated the data requirement for these studies to your firm separately in advisories included in the decision letters for the interim reports.  
The 522 Order recommends that your firm conducts the Sampling and Culturing Study in two phases, starting with a pilot phase during which your firm starts data collection and collect culturing samples from clinically used and reprocessed duodenoscopes for continued sample collection in the second phase of the study. The 522 Order states that “FDA expects you [your firm] will commence data collection for Phase 2 within 15 months of the date of the Postmarket Surveillance order.” Section 522 of the Act requires a firm to “commence surveillance . . . not later than 15 months after the day on which the Secretary issues an order under this section.” However, your firm has failed to provide sufficient data with commencement of data collection within 15 months after issuance of the 522 Order.
A study plan for the Sampling and Culturing Study was approved on December 8, 2016. Per the approved study plan, your firm is required to conduct a Phase 1 and 2 study that collects a total of 850 samples. Under the Phase 1 study, your firm was required to enroll two (2) sites and collect 85 samples by May 2017. However, as of February 2, 2018, only 20 samples for the Phase 1 study have been collected at the two enrolled (2) sites. On November 27, 2017, FDA held a teleconference meeting with your firm outlining that your firm had not fulfilled the requirements of the 522 Order, the established timeline for enrollment of sites and collection of samples, and that your firm’s study status would be changed to “Noncompliant.” FDA issued decision letters to your firm on February 22, 2017, April 20, 2017, June 8, 2017, September 7, 2017, November 9, 2017, and January 31, 2018 with advisories stating that your firm was not meeting the milestones per the agreed study plan and timeline.
A study plan for the Human Factors Study was approved on August 10, 2017.  Per the approved study timeline, the study was expected to have the first test participant enrolled by August 2017, have six (6) test participants enrolled per month, and have data collection completed by January 2018. However, as of the interim report dated February 2, 2018, your firm has zero (0) participants enrolled and human factors testing has not commenced. A decision letter was sent to your firm on January 6, 2018 with an advisory stating that your firm was not meeting the milestones per the agreed plan and timeline.
Failure of a manufacturer to comply with requirements under section 522 of the Act, which includes requirements specified under 21 CFR Part 822, is a prohibited act under section 301(q)(1)(C) of the Act, 21 U.S.C. § 331(q)(1)(C). Further, failure to comply with a requirement under section 522 of the Act renders a device misbranded under section 502(t)(3) of the Act (21 U.S.C. § 352(t)(3)). 
Your firm has committed a prohibited act under section 301(q)(1)(C) of the Act by failing to comply with requirements under section 522 of the Act, and your duodenoscope model ED-3490TK is currently misbranded under section 502(t)(3) of the Act.
Your firm should take prompt action to correct this violation. Failure to promptly correct this violation may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Please note that Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Within fifteen (15) calendar days from the date you receive this letter, please submit a plan that outlines how the milestones below will be achieved:
Sampling and Culturing Study
  • Process 50% of all samples by August 31, 2018
  • Process 100% of all samples by December 31, 2018
Human Factors Study
  • Complete 50% of human factors testing by May 31, 2018
  • Complete 100% of human factors testing by June 30, 2018
Your firm should notify this office in writing of the specific steps your firm has taken to correct the noted violations. Include documentation of the corrective actions your firm has taken. If your firm’s planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective actions cannot be completed within fifteen (15) calendar days, state the reason for the delay and the time within which the corrections will be completed.
Your firm’s response to this letter should be sent to:
522 Postmarket Surveillance Studies Program
Food and Drug Administration
Center for Devices and Radiological Health
10903 New Hampshire Avenue
Building 66, Room 2252
Silver Spring, Maryland 20993-0002
If you have any questions about the content of this letter, please contact:
Attention: LCDR Cesar Perez
Chief, Surveillance and Enforcement Branch I
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
Division of Premarket and Labeling Compliance
10903 New Hampshire Avenue
Building 66, Room 3626
Silver Spring, Maryland 20993-0002
Finally, you should understand that there are many FDA requirements pertaining to the manufacture and marketing of devices. This letter pertains only to the issue of postmarket surveillance requirements for the device subject to the 522 Order dated October 5, 2015 and does not necessarily address other obligations your firm has under the law.
William H. Maisel, MD, MPH
Acting Director
Office of Compliance
Center for Devices and Radiological Health
William Goeller
Vice President, Quality Assurance and Regulatory Affairs
Pentax Medical- A Division of Pentax of America, Inc. 
3 Paragon Drive
Montvale, New Jersey 07645
Mr. Hiroshi Suzuki
President and CEO
Hoya Corporation (PENTAX Life Care Division)
Showanomori Technology Center
1-1-110 Tsutsujigaoka, Akishima-shi
Tokyo 196-0012

Page Last Updated: 03/09/2018
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