Seiki Co., Ltd.

CLOSEOUT LETTER Seiki Co., Ltd. MARCS-CMS 523744 — March 28, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Seiki Co., Ltd. United States Issuing Office: United States 5001 Campus Drive College Park, MD 20740 March 28, 2018 Mr. Kenji Kuroiwa President Seiki Co., Ltd. 7922-3 Kiire Maenohama-Cho Kagoshima City, Kagoshima Prefecture Japan 891-0205 Dear Mr. Kuroiwa: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #523744, issued June 1, 2017. Based on our evaluation, it appears that you have addressed the violations 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/ Maria Corpuz Team Leader Food Adulteration Assessment Branch Division of Enforcement Office of Compliance Center for Food Safety and Applied Nutrition Content current as of: 04/02/2018