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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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BC Group International Inc. - Close Out Letter 1/6/12


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 80th Street
Lenexa, Kansas 66214
Telephone: (913) 752-2100

January 6, 2012

Ref. KAN2011-06

Mr. Melvin L. Roche, President
BC Group International Inc.
3081 Elm Point Industrial Dr.
Saint Charles, MO 63301-4333

Dear Mr. Roche:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter Ref. KAN 2011-06 dated March 23, 2011. 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.



John W. Thorsky
District Director
Kansas City District