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CLOSEOUT LETTER

AMS Health Sciences, LLC Apr 25, 2016

AMS Health Sciences, LLC - Close Out Letter 4/25/16


AMS Health Sciences, LLC

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Food and Drug Administration
 Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128

April 25, 2016


UPS OVERNIGHT MAIL

Dhamendra Lachman, Owner and COO
AMS Health Sciences, LLC
711 NE 39th Street
Oklahoma City, OK 73105-7219

Dear Mr. Lachman:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, 2014-DAL-WL-14, issued on July 25, 2014. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.


Sincerely,

/S/

Shari J. Shambaugh
Director, Compliance Branch
Dallas District Office

 

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