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

[email protected] Issuing Office: Office of Compliance and Biologics Quality

United States

Secondary Issuing Offices

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 [email protected].

Sincerely,
/S/
Melissa J. Mendoza
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research