Pentax of America, Inc.

CLOSEOUT LETTER Pentax of America, Inc. January 26, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Pentax of America, Inc. United States Issuing Office: United States Office of Medical Device and Radiological Health Operations (Division 1) One Montvale Avenue Stoneham, MA 02180 January 26, 2018 David Woods President PENTAX of America, Inc. 3 Paragon Drive Montvale, New Jersey 07645-1725 Dear Mr. Woods, The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to the Warning Letter [13-NWJ-06, dated March 29, 2013], issued to KayPENTAX, A Division of PENTAX Medical Company. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. 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, /S/ Gina Brackett Acting Director, Compliance Branch Office of Medical Device and Radiological Health Operations, Division 1 Content current as of: 01/30/2018