Biotek, Inc.

CLOSEOUT LETTER Biotek, Inc. MARCS-CMS 539361 — July 08, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Dietary Supplements Recipient: Recipient Name Norman J. Larsen Recipient Title President Biotek, Inc. 334 Marshall Way N Suite F Layton , UT 84041 United States Issuing Office: Office of Human and Animal Foods Division IV West United States Dear Mr. Larsen: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, reference # HAF4W (DEN)-18-04-WL, issued March 13, 2018. Based on our evaluation, it appears that you have addressed the violation(s) contained in the referenced 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/ LaTonya M. Mitchell, Ph.D. Denver District Director Program Division Director Office of Human and Animal Foods Division IV West Content current as of: 07/08/2020 Regulated Product(s) Dietary Supplements