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CLOSEOUT LETTER

Hieber's Pharmacy MARCS-CMS 542220 —

Product:
Drugs

Recipient:
Recipient Name
Ms. Rosemary E. Mihalko, RPh
Recipient Title
Owner
Hieber's Pharmacy

3500 5th Avenue
Pittsburgh, PA 15213-3337
United States

Issuing Office:
Office of Pharmaceutical Quality Operations Division I/New Jersey District

United States

(973) 331-4900

Dear Ms. Mihalko:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter #15-PHI-20, dated September 20, 2015, and our warning letter #542220, dated December 5, 2017. Based on our evaluation, it appears that you have adequately addressed the violations contained in these warning letters.

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/
Diana Amador-Toro
Program Division Director
Office of Pharmaceutical Quality Operations
Division I/New Jersey District