Dorneyville Pharmacy

CLOSEOUT LETTER Dorneyville Pharmacy MARCS-CMS 510866 — June 22, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Certified Email Recipient: Recipient Name Thomas E. Silvonek Recipient Title Owner 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. Sincerely, /S/ Stephanie Durso, Director Compliance Branch Office of Pharmaceutical Quality Operations, Division I Content current as of: 09/21/2020