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  5. Integrated Health Concepts Inc. - 610546 - 01/18/2022
  1. Warning Letters

CLOSEOUT LETTER

Integrated Health Concepts Inc. MARCS-CMS 610546 —

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

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