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CLOSEOUT LETTER

Health Innovations Pharmacy, Inc MARCS-CMS 489187 —

Recipient:
Health Innovations Pharmacy, Inc

United States

Issuing Office:

United States

 

   

Black HHS-Blue FDA Logo

 

 
 
Office of Pharmaceutical Quality Operations, Division 2
4040 N. Central Expressway, Suite 300
Dallas, Texas 75204

April 21, 2018

Mr. Timothy H. Clark, Owner
Health Innovations Pharmacy, Inc.
295 Pinehurst Avenue
Southern Pines, North Carolina 28387

Mr. Clark:

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 #16-ATL-16] issued on July 8, 2016. We acknowledge that your firm no longer produces sterile drug products. 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 assure 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.

If you have additional questions, please contact me at (214) 253-5288 or john.diehl@fda.hhs.gov.

Sincerely,
/S/

LCDR John W. Diehl, M.S.
Director, Compliance Branch
Office of Pharmaceutical Quality Operations, Division 2 

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