Saffron USA LLC

CLOSEOUT LETTER Saffron USA LLC MARCS-CMS 629821 — January 09, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Reference #: 23-HAFE4-WLCOL-01 Product: Dietary Supplements Recipient: Recipient Name Ms. Farangis Sedaghat Recipient Title Owner Saffron USA LLC 504 Spring Island Way Orlando , FL 32828 United States ftsedaghat@yahoo.com Issuing Office: Division of Human and Animal Food Operations East IV United States Dear Ms. Sedaghat: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 22-HAFE4-WL-07 dated September 23, 2022. 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. Kind regards, /S/ Pearl Lopina Director of Compliance Branch OHAFO, East Division IV Content current as of: 01/17/2023 Regulated Product(s) Dietary Supplements