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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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KHL INC - Closed Out Letter 5/20/10

   

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

Public Health Service
Food and Drug Administration
  10903 New Hampshire Ave.
Silver Spring, MD 20993

MAY 20, 20010

 


Ms. Anne M. Leask
President
KHL Inc.
18300 NE 146th Way
Woodinville, WA 98072

 

Dear Ms. Leask:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter dated March 17, 2010. 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/

Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and Radiological Health