Golden Lab LLC

CLOSEOUT LETTER Golden Lab LLC MARCS-CMS 625783 — March 22, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Reference #: 24-HAFE4-WLCOL-05 Product: Drugs Food & Beverages Recipient: Recipient Name Dr. Howard J. Loff, M.D. Recipient Title Owner and CEO Golden Lab LLC 2375 Saint Johns Bluff Rd S Ste 310 Jacksonville , FL 32246-2335 United States Hloffmd@doctorsoptimalformula.com Issuing Office: Office of Human and Animal Food Operations East Division IV United States Secondary Issuing Offices United States Dear Dr. Loff: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 22-HAFE4-WL-05 dated May 26, 2022. 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. Kind regards, /S/ Pearl E. Lopina Director of Compliance Branch OHAFO, Division IV East Content current as of: 04/03/2024 Regulated Product(s) Drugs Food & Beverages