Saffron Health Sciences

CLOSEOUT LETTER Saffron Health Sciences MARCS-CMS 615429 — January 18, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Next Day Air Product: Dietary Supplements Recipient: Recipient Name Dr. Song Gao Saffron Health Sciences 13 Dexter Rd E Brunswick , NJ 08816-2873 United States natureway62@gmail.com Issuing Office: Division of Human and Animal Food Operations East II United States Dear Dr. Gao; The Food & Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS #615429, dated November 18, 2021. 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 further regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ Andrew Howard Consumer Safety Officer/Compliance Officer Office of Human and Animal Food East II Baltimore District Office U.S. Food and Drug Administration Tel: 410-779-5125 Andrew.Howard@fda.hhs.gov Content current as of: 02/15/2022 Regulated Product(s) Dietary Supplements