GC Natural

CLOSEOUT LETTER GC Natural MARCS-CMS 547463 — March 31, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: United Parcel Service Product: Dietary Supplements Recipient: Recipient Name Ms. Chun H. Guo, Mr. Wen Z. Guo Recipient Title Secretary and Owner, President and Owner GC Natural 6081 Dale St., Ste. B Buena Park , CA 90621-4161 United States Issuing Office: Office of Human and Animal Food Operations West Division 5 United States Dear Ms. Guo and Mr. Guo: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 547463 issued July 13, 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/ Sergio Chavez, Compliance Branch Director Office of Human and Animal Food Operations West Division 5 Content current as of: 04/24/2020 Regulated Product(s) Dietary Supplements