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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Platinum Strategies, Inc - Close Out Letter 7/7/10

 

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

Public Health Service
Food and Drug Administration
 Detroit District
300 River Place
Suite 5900
Detroit, MI 48207
Telephone: 313-393-8100

July 7, 2010


Mr. Jamie Miralles
Platinum Strategies, Inc.
1500 N. Curry Pike
Bloomington, IN 47404


Dear Mr. Miralles:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 2009-DET-19 of September 23, 2009. 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/

Joann M. Givens
District Director
Detroit District Office