CLOSEOUT LETTER

Tailstorm Health Inc. dba Medivant Health MARCS-CMS 703497 — March 23, 2026

Delivery Method:: VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT
Product:: Drugs

Recipient:: Recipient Name

Viraj Gandhi; Recipient Title

Chief Executive Officer; Tailstorm Health Inc. dba Medivant Health; 24416 N. 19th Avenue Suite 200
Phoenix, AZ 85085-1400
United States

Issuing Office:: Center for Drug Evaluation and Research (CDER); United States

Secondary Issuing Offices

United States

Dear Mr. Gandhi:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter #703497, issued on April 8, 2025. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter.

You are expected to take all necessary steps to ensure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely,
/S/
Matthew J. Lash
Acting Director
Office of Compounding Quality and Compliance
Office of Compliance
Center for Drug Evaluation and Research