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CLOSEOUT LETTER

Jeffreys Drug Store MARCS-CMS 495144 —


Recipient:
Jeffreys Drug Store

United States

Issuing Office:

United States


 

   

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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 

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