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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Performance Products Inc - Close Out Letter 7/16/13


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

Public Health Service
 Food and Drug Administration
Kansas City District
Southwest Region
8050 Marshall Drive, Suite 205
Lenexa, Kansas 66214-1524

Telephone: (913) 495-5100


July 16, 2013


Mr. Joseph R. Warnhoff, President
Performance Products, Inc.
1212 Pierce Ave.
Saint Louis, MO 63110

Dear Mr. Warnhoff:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter KAN-2012-02 dated November 20, 2012. 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.




Danial S. Hutchison
Compliance Officer
Kansas City District