Annemarie Gianni Skin Care LLC

CLOSEOUT LETTER Annemarie Gianni Skin Care LLC MARCS-CMS 495979 — February 12, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Dietary Supplements Recipient: Recipient Name Annmarie and Kevin Gianni Recipient Title Founders Annemarie Gianni Skin Care LLC 2251 5th St Berkeley , CA 94710-2216 United States Issuing Office: Office of Human and Animal Food Operations East - Division 1 United States Dear Ms. Gianni and Mr. Gianni: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS # 495979 dated July 15, 2016. 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 subsequent inspection or through other means. Sincerely, /S/ CDR Catherine M. Beer Director, Compliance Branch Office of Human and Animal Food Operations East - Division 1 Content current as of: 02/18/2020 Regulated Product(s) Dietary Supplements