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CLOSEOUT LETTER

Eastern Pharmacy, Inc.


Eastern Pharmacy, Inc.

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
Florida District
 555 Winderley Place, Suite 200
Maitland, Florida 32751
Telephone: 407-475-4700
FAX: 407-475-4770

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED

August 1, 2016
 

Daoud Zayed, Owner
Eastern Pharmacy, Inc.
2046 W. Silver Springs Blvd
Ocala, FL 34475

Dear Mr. Zayed:

The U.S. Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our warning letter (ref: WL# FLA-15-02) dated October 29, 2014. We acknowledge that your firm ceased sterile compounding operations on January 2, 2014, and subsequently ceased all compounding operations. Therefore, there are no remaining compounding-related issues.

Should you choose to resume compounding operations, 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/

Susan M. Turcovski
Director, Florida District