U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Health Innovations Pharmacy, Inc - Close Out Letter 4/21/18
  1. Warning Letters

CLOSEOUT LETTER

Health Innovations Pharmacy, Inc


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