Delivery Method: VIA EMAIL CONFIRMED DELIVERY Product: Drugs

Recipient:

Recipient Name

Taylor Cline

Recipient Title

Chief Executive Officer and President

Integrated Health Concepts Inc.

720 Aerovista Place
Suite D
San Luis Obispo, CA 93401-8726
United States

Issuing Office: Division of Pharmaceutical Quality Operations IV

United States


Dear Mr. Taylor Cline:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (WL 610546) dated September 10, 2020. 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/
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV