S.S.O., Inc dba BYS Company

CLOSEOUT LETTER S.S.O., Inc dba BYS Company MARCS-CMS 496434 — October 09, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: United Parcel Service Product: Food & Beverages Recipient: Recipient Name James W. Sims Recipient Title President S.S.O., Inc dba BYS Company 18273 Grand Ave. #5&8 Lake Elsinore , CA 92530-6118 United States Issuing Office: Center for Food Safety and Nutrition 19701 Fairchild Irvine , CA 92612 United States Dear Mr. Sims: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 49-16 issued September 23, 2016 (CMS # 496434). 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/ Sergio Chavez, Director, Compliance Branch Food and Drug Administration Office of Human and Animal Foods Division West 5 19701 Fairchild Irvine, CA 92612 Content current as of: 10/21/2019 Regulated Product(s) Food & Beverages