CLOSEOUT LETTER

Empower Clinic Services, LLC MARCS-CMS 516718 — October 22, 2018

Reference #:: 3011887629
Product:: Drugs

Recipient:: Recipient Name

Arta Shaun Noorian; Recipient Title

Owner; Empower Clinic Services, LLC; Empower Clinic Services, LLC; 5980 W Sam Houston Parkway North
Suite 300
Houston, TX 77041
United States

Issuing Office:: Division of Pharmaceutical Quality Operations II; 4040 N. Central Expressway
Suite 300
Dallas, TX 75204
United States; (214) 253-5200

October 22, 2018

Reference: FEI #3011887629
CMS Case #516718

UPS OVERNIGHT MAIL

Arta Shaun Noorian, Owner
Empower Clinic Services, LLC dba Empower Pharmacy
5980 West Sam Houston Parkway North, Suite 300
Houston, Texas 77041

Mr. Noorian,

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s response to our warning letter (Reference CMS Case #516718) dated May 25, 2017. From November 9, 2015, to November 25, 2015, FDA investigators conducted an inspection of your facility, Empower Clinic Services, LLC, located at 12123 Jones Rd., Houston, Texas 77070. We acknowledge that your firm ceased compounding operations on April 2, 2016 and moved to its newly constructed facility located at 5980 West Sam Houston Pkwy North, Suite 300, Houston, Texas 77041, and registered as a 503B outsourcing facility on July 16, 2016.

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 about this letter, you may contact me by e-mail at John.Diehl@fda.hhs.gov or by phone at 214-253-5288.

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