Harold Brey & Sons Inc.

CLOSEOUT LETTER Harold Brey & Sons Inc. MARCS-CMS 585292 — April 02, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UNITED PARCEL SERVICE Product: Food & Beverages Recipient: Recipient Name Mr. Daniel Brey & Ms. Nancy Brey Recipient Title Co-Owners Harold Brey & Sons Inc. 607 Swiss Hill Rd. Jeffersonville , NY 12748 United States Issuing Office: Office of Human and Animal Food Operations East Division 1 United States Dear Mr. & Ms. Brey: The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 585292, issued on September 24, 2019. 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/ Scott M. Loughan Acting Director, Compliance Branch Office of Human and Animal Food Operations East Division 1 Content current as of: 04/10/2020 Regulated Product(s) Food & Beverages