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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Reaction Nutrition LLC - Close Out Letter 11/08/2012


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

Public Health Service
Food and Drug Administration
 Philadelphia District Office
900 U.S. Customhouse
2nd and Chestnut-Streets
Philadelphia, PA 19106
Telephone: 215-597-4390


 November 8, 2012



Frank Bedoloto, CEO, Partner
Reaction Nutrition, L.L.C.
230 East Main Street
Carnegie, PA 15106-2700

Dear Mr. Bedoloto:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter 12-PHI-16, dated May 8, 2012. Based on our evaluation, it appears that you have addressed the violation(s) contained in the 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 you firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and it 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.



Steven L. Carter
Director, Compliance Branch