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CLOSEOUT LETTER

Abrams Royal Pharmacy Sep 28, 2016

Abrams Royal Pharmacy - Close Out Letter 9/28/16


Abrams Royal Pharmacy

 

  

Department of Health and Human Services logoDepartment of Health and Human Services logo

 

 
 
Dallas District Office
4040 North Central Expressway, Suite 300
Dallas, TX 75204-3158

September 28, 2016
 

UPS OVERNIGHT MAIL

Bob Scarbrough, R.Ph, Owner
Abrams Royal Pharmacy, Inc.
8220 Abrams Road
Dallas, TX 75231-1402
 

Dear Mr. Scarbrough,

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our warning letter (ref: 2014-DAL-WL-12) dated July 14, 2014. We acknowledge that your firm no longer produces sterile drug products. 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 its 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/
Shari J. Shambaugh
Director, Compliance Branch
Dallas District