Inspections, Compliance, Enforcement, and Criminal Investigations

Nora Apothecary Pharmacy - Close Out Letter 8/10/17

 

  

Black HHS-Blue FDA Logo

 

Division of Pharmaceutical Quality Operations III
300 River Place, Suite 5900
Detroit, MI 48207
Telephone: (313) 393-8100
Fax: (313) 393-8139

 
 

August 10, 2017

Anthony S. Kantzavelos, PharmD
President & Owner
RxCompounding, Inc.
1101 E 86th St.
Indianapolis, IN 46240-3729

Dear Dr. Kantzavelos:

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 2014-DET-05, February 14, 2014). Based on our evaluation of the documentation you provided, it appears that you have adequately addressed most of 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.

Sincerely,
/S/

Nicholas Lyons
Compliance Director
Division of Pharmaceutical Quality Operations III 

Page Last Updated: 08/11/2017
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