CLOSEOUT LETTER

American Specialty Pharmacy MARCS-CMS 513239 — November 07, 2018

Delivery Method:: UPS EXPRESS

Recipient:: Recipient Name

Abdul Hameed; Recipient Title

President/Owner; American Specialty Pharmacy; American Specialty Pharmacy; 13988 Diplomat Drive
Ste 100
Farmers Branch, TX 75234
United States

Issuing Office:: Office of Pharmaceutical Quality Operations; 4040 N. Central Expressway
Suite 300
Dallas, TX 75204
United States

November 7, 2018

VIA UPS EXPRESS

Abdul Hameed. President/Owner
ASP Cares
13988 Diplomat Drive, Ste 100
Farmers Branch, Texas 75234

Mr. Hameed:

This letter acknowledges receipt of your letter dated April 10, 2017, in which you responded to FDA’s warning letter (ref: WL# 2017-DAL-WL-13) dated April 4, 2017. FDA acknowledges your statement that “the sterile division at 10 Medical Parkway was permanently closed [] and [your firm does not] intend to resume production of sterile drugs in the future.” We acknowledge that your firm has ceased production at the Medical Parkway facility. Therefore, there are no remaining compounding-related issues.

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 any questions regarding this letter, you may contact me by telephone at (214) 253-5288.

Sincerely,
/S/
LCDR John W. Diehl, M.S
Director, Compliance Branch
Office of Pharmaceutical Quality Operations, Division II