NeuroHydrate LLC

CLOSEOUT LETTER NeuroHydrate LLC MARCS-CMS 613092 — June 21, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UNITED PARCEL SERVICE Product: Dietary Supplements Recipient: Recipient Name Hamid Sami, Justin Higgins Recipient Title Founding Partner, Managing Partner NeuroHydrate LLC United States Issuing Office: Office of Human and Animal Food Operations East – Division 1 United States Dear Mr. Sami and Mr. Higgins: The Food and Drug Administration has completed evaluation of your firm's corrective actions in response to our Warning Letter CMS# 613092, issued on April 27, 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 future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ CDR Catherine Beer Director, Compliance Branch Office of Human and Animal Food Operations East Division 1 Content current as of: 06/23/2021 Regulated Product(s) Dietary Supplements