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  5. Empower Clinic Services, LLC - 516718 - 10/22/2018
  1. Warning Letters

CLOSEOUT LETTER

Empower Clinic Services, LLC MARCS-CMS 516718 —

Delivery Method:
UPS OVERNIGHT MAIL
Reference #:
3011887629
Recipient:
Recipient Name
Arta Shaun Noorian
Recipient Title
Owner
Empower Clinic Services, LLC
Empower Clinic Services, LLC

5980 West 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

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

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