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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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G.T. Laboratories, Response Letter

G.T. Laboratories, Inc. Central Park of Lisle Center, 3333 Warrenville Road, Suite 200, Lisle, IL 60532 USA, (800) 321-4060, (847) 998-4776, Fax (847) 998-1730

 

 

May 17, 2006

 

Patrick J. Brown
Compliance Officer
U.S. Food & Drug Administration
Chicago, District Office
550 West Jackson Blvd.
Chicago, IL 60661-5716

Dear Mr. Brown,

Request the following response to the Warning Letter CHI-18-04, dated August 31, 2004, be posted on the FDA web site:

Upon being informed of the results of the July 12, 2004 audit, the company took immediate effective action on all items cited in the audit in full cooperation with the FDA. The FDA noted our response dated July 20, 2004, to correct the deviations cited in the Warning Letter and stated they would verify the adequacy of our corrective actions during a subsequent inspection.

On April 4, 2006, a follow-up inspection was conducted by the FDA and their assessment indicates that the company is currently operating in full compliance with the Federal Food and Drug, and Cosmetic Act. They found no deficiencies or violations during the inspection and noted that the deficiencies described in the Warning Letter have been fully corrected.

 

Sincerely,


/s/

Sam G. Tripas
President

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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