American Specialty Pharmacy

CLOSEOUT LETTER American Specialty Pharmacy MARCS-CMS 513239 — November 07, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 Content current as of: 11/13/2018