Jeffreys Drug Store

CLOSEOUT LETTER Jeffreys Drug Store MARCS-CMS 495144 — August 16, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Jeffreys Drug Store United States Issuing Office: United States Division of Pharmaceutical Quality Operations I 10 Waterview Blvd, 3rd Floor Parsippany, NJ 07054 Telephone: (973) 331-4900 FAX: (973) 331-4969 VIA UNITED PARCEL SERVICE August 16, 2018 Gerald E. O’Hare, R. Ph. President Jeffreys Drug Store 1 N. Central Avenue Canonsburg, PA 15371 Dear Mr. O’Hare: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter # 16-PHI-12 dated August 25, 2016. 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 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/ Stephanie Durso OPQO Division I Director Compliance Branch Content current as of: 09/17/2018