CLOSEOUT LETTER
Empower Clinic Services, LLC MARCS-CMS 516718 —
- Reference #:
- 3011887629
- Product:
- Drugs
- Recipient:
-
Recipient NameArta Shaun Noorian
-
Recipient TitleOwner
- 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
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