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Dorneyville Pharmacy MARCS-CMS 510866 —

Delivery Method:
Via Certified Email

Recipient Name
Thomas E. Silvonek
Recipient Title
Dorneyville Pharmacy

3330 Hamilton Blvd.
Allentown, PA 18103-4537
United States

Issuing Office:
Office of Pharmaceutical Quality Operations, Division I

United States

Dear Mr. Silvonek:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (17-PHI-05, February 7, 2017). 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 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.

Stephanie Durso, Director Compliance Branch
Office of Pharmaceutical Quality Operations, Division I

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