Inspections, Compliance, Enforcement, and Criminal Investigations
Reaction Nutrition LLC - Close Out Letter 11/08/2012
| Public Health Service Food and Drug Administration |
| Philadelphia District Office PHILADELPHIA DISTRICT 900 U.S. Customhouse 2nd and Chestnut-Streets Philadelphia, PA 19106 Telephone: 215-597-4390 |
Department of Health and Human Services
November 8, 2012
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
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.
Sincerely,
/S/
Steven L. Carter
Director, Compliance Branch
