Soterion Development, Inc.

CLOSEOUT LETTER Soterion Development, Inc. MARCS-CMS 586355 — May 04, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Food & Beverages Recipient: Recipient Name Mr. Gilberto Cedeno Recipient Title General Manager/Owner Soterion Development, Inc. Avenue 2nd West, David Pedregal Chiriqui Panama Issuing Office: Center for Food Safety and Applied Nutrition United States Dear: Mr. Cedeno: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 586355, issued August 19, 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/ Robyn R. Jones Division of Enforcement Office of Compliance Center for Food Safety and Applied Nutrition Content current as of: 05/12/2021 Regulated Product(s) Food & Beverages