BioXtek LLC

CLOSEOUT LETTER BioXtek LLC MARCS-CMS 715478 — February 11, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Biologics Medical Devices Recipient: Recipient Name Bruce R. Werber, DPM Recipient Title Chief Executive Officer and Founder BioXtek LLC 316 NE 1st St Pompano Beach , FL 33060 United States docw@bioxtek.com Issuing Office: Office of Compliance and Biologics Quality United States Secondary Issuing Offices United States Dear Dr. Werber: The Food and Drug Administration (FDA) has completed its evaluation of your firm's corrective actions in response to our Warning Letter dated December 1, 2025, as detailed in your correspondence dated December 11, 2025. Based on your removal of the video containing the cited claims from your website and your representation that the video has been removed from other public platforms, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will 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. If you have questions regarding this letter, contact the Division of Case Management, CBER at (240) 402-9156 or email CBERDCMRecommendations@fda.hhs.gov. Sincerely, /S/ Melissa J. Mendoza Director Office of Compliance and Biologics Quality Center for Biologics Evaluation and Research Content current as of: 02/19/2026 Regulated Product(s) Biologics Medical Devices