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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Centaur, Inc. Close out Letter 5/9/11

  

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

Public Health Service
Food and Drug Administration
 Kansas City District
Southwest Region
11630 West 80 Street
Lenexa, Kansas 66214-3340
Telephone: (913) 752-2100 

 

May 9, 2011


CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Mark Metrokotsas
President and Chief Operating Officer
Centaur, Inc.
1351 Old 56 Hwy, Building C
Olathe, KS 66061


Dear Mr. Metrokotsas,


The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter [KAN 2010-03, January 8, 2010]. 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/

John W. Thorsky
District Director
Kansas City District