McClure's Lancaster Old Fashioned, LLC

CLOSEOUT LETTER McClure's Lancaster Old Fashioned, LLC MARCS-CMS 670611 — July 21, 2025 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Dietary Supplements Recipient: Recipient Name Mr. Thomas Keenan Recipient Title Owner & President McClure's Lancaster Old Fashioned, LLC 1212 Reading Road Bowmansville , PA 17507 United States Issuing Office: Division of Human and Animal Food Operations East II United States Secondary Issuing Offices United States Dear Mr. Keenan: The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (#670611) on May 16, 2024. 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/ Robyn R. Jones, Branch Chief Conventional Foods Enforcement Branch 2 Office of Compliance and Enforcement Human Foods Program Content current as of: 07/28/2025 Regulated Product(s) Dietary Supplements