PT. SIG ASIA

CLOSEOUT LETTER PT. SIG ASIA MARCS-CMS 592584 — December 17, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Food & Beverages Seafood/Seafood Product Recipient: Recipient Name Shaun Tan Recipient Title Chairwoman PT. SIG ASIA Jl. Lumba-Lumba Lingkungan IV, RT. 01, RW. 04 Kel. Girian Bawah, Kec. Girian Bitung Sulawesi Utara 95542 Indonesia Issuing Office: Center for Food Safety and Applied Nutrition (CFSAN) 5001 Campus Drive College Park , MD 20740 United States Dear Ms. Tan: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #592584, issued October 28, 2019. Based on our evaluation, it appears you have addressed the violations contained in the 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/ Mildred P. Benjamin Branch Chief Division of Enforcement Office of Compliance Center for Food Safety and Applied Nutrition Content current as of: 03/09/2020 Regulated Product(s) Food & Beverages Seafood/Seafood Product