Suntraco Food Industries SDN BHD

CLOSEOUT LETTER Suntraco Food Industries SDN BHD MARCS-CMS 545371 — May 10, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Electronic Mail Recipient: Recipient Name Tang Hang Seng Recipient Title Managing Director Suntraco Food Industries SDN BHD Suntraco Food Industries SDN BHD No. 1 & 3 JLN Korporat 3KU9 Taman Perindustrian Neru 42200 Klang Selangor Malaysia hs.tang@suntracofood.com Issuing Office: United States Dear Seng: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #545371, issued February 8, 2018. 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/ Robyn Jones, Team Leader Food Adulteration and Assessment Branch Division of Enforcement Office of Compliance Center for Food Safety and Applied Nutrition Content current as of: 10/25/2018