A&Z Pharmaceutical Inc

CLOSEOUT LETTER A&Z Pharmaceutical Inc MARCS-CMS 645101 — May 24, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Dietary Supplements Recipient: Recipient Name Emma Qingbo Li Xu Recipient Title Chairwoman/CEO A&Z Pharmaceutical Inc 180 Oser Ave., Suite 300 Hauppauge , NY 11788-3709 United States emmaerwin@azpharmaceutical.com Issuing Office: Division of Human and Animal Food Operations East I United States Secondary Issuing Offices United States Dear Ms. Li Xu: The Food and Drug Administration has completed evaluation of your firm's corrective actions in response to our Warning Letter CMS# 645101, issued on June 1, 2023. 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/ Lillian C. Aveta Acting Director, Compliance Branch (ADCB) Office of Human and Animal Food Operations East Division 1 Content current as of: 05/30/2024 Regulated Product(s) Dietary Supplements