CLOSEOUT LETTER
Nora Apothecary Pharmacy
- Recipient:
- Nora Apothecary Pharmacy
United States
- Issuing Office:
United States
Division of Pharmaceutical Quality Operations III | |
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