U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. American Specialty Pharmacy - Close Out Letter 7/28/17
  1. Compliance Actions and Activities

CLOSEOUT LETTER

American Specialty Pharmacy 28/07/2017

American Specialty Pharmacy - Close Out Letter 7/28/17


American Specialty Pharmacy

 

  

Black HHS-Blue FDA Logo

 

Office of Pharmaceutical Quality Operations, Division II
4040 N. Central Expressway, Suite 300
Dallas, Texas 75204

 
 

July 28, 2017

Abdul Hameed, Owner
American Specialty Pharmacy, Inc.
13988 Diplomat Drive, Suite 100
Farmers Branch, Texas 75234

Dear Mr. Hameed:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your response to our warning letter (WL# 2016-DAL-WL-27) dated June 28, 2016. From June 13, 2017, to June 14, 2017, FDA investigators conducted an inspection of your facility, American Specialty Pharmacy, located at 2743 W. 15th Street, Plano, Texas 75075-7525. We acknowledge that your firm has ceased production of drugs at this facility.

If you decide to resume compounding operations in the future, please provide an explanation of each step taken to prevent the recurrence of the violations cited in the warning letter, as well as copies of related documentation. In addition to taking appropriate corrective actions, your firm should notify this office prior to resuming production of any drug products in the future.

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.

If you have additional questions, please contact me at 214-253-5288.

Sincerely,
/S/

John W. Diehl
Acting Director, Compliance Branch
Office of Pharmaceutical Quality Operations, Division II