Hoya Corporation - Pentax Life Division

CLOSEOUT LETTER Hoya Corporation - Pentax Life Division MARCS-CMS 546991 — April 04, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Ojas A. Buch Recipient Title President Hoya Corporation - Pentax Life Division PENTAX Medical - Americas 3 Paragon Drive Montvale , NJ 07645 United States Issuing Office: Center for Devices and Radiological Health United States Dear Ojas A. Buch: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 546991, dated March 9, 2018). Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely yours, /S/ Courtney H. Lias, Ph.D. Director OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Center for Devices and Radiological Health CC: 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 Japan Content current as of: 04/08/2022 Regulated Product(s) Medical Devices