Alternative Laboratories

CLOSEOUT LETTER Alternative Laboratories MARCS-CMS 586947 — May 21, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Reference #: 20-HAFE4-WLCOL-10 Product: Dietary Supplements Recipient: Recipient Name Mr. Kevin J. Thomas Recipient Title CEO Alternative Laboratories 2231 Linwood Avenue Naples , FL 34112-4737 United States kevin@alternativelabs.com Issuing Office: Office of Human and Animal Food Operations Division IV East United States (787) 729-8500 Dear Mr. Thomas: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 19-HAFE4-WL-10 dated September 18, 2019. 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/ Edwin Ramos Director of Compliance Branch OHAFO, Division IV East Content current as of: 05/26/2020 Regulated Product(s) Dietary Supplements