Inspections, Compliance, Enforcement, and Criminal Investigations

ArjoHuntleigh Inc. - Close Out Letter 7/21/15

  

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

Food and Drug Administration
 Dallas District Office
4040 North Central Expressway
Suite 300
Dallas, Texas 75204
 

July 21, 2015

UPS Overnight

Julie A. Burgett, VP Global Program Management
ArjoHuntleigh, Inc.
12625 Wetmore Road
San Antonio, Texas 78247

Dear Ms. Burgett:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter 2014-DAL-WL-19, dated September 18, 2014. Based on our evaluation, it appears that you have addressed the violation(s) 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

Page Last Updated: 07/27/2015
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