Allay Pharmaceuticals, LLC

CLOSEOUT LETTER Allay Pharmaceuticals, LLC MARCS-CMS 609023 — July 18, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Rosy Sultana Recipient Title CEO & President Allay Pharmaceuticals, LLC 16600 NW 54th Ave Unit 23 Hialeah , FL 33014-6109 United States Issuing Office: Division of Pharmaceutical Quality Operations II United States Ms. Sultana: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (CMS No. 609023) dated January 27, 2021. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter. You are expected to take all necessary steps to ensure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ Shawn Larson, PhD Acting Director, Compliance Branch Office of Pharmaceutical Quality Operations, Division II Content current as of: 07/25/2022 Regulated Product(s) Drugs