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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Bob L. Osborn - Close Out Letter 10/1/12

  

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, Ml 48207
Telephone: 313-393-8100
FAX: 313-393-8139
 


 

October 1, 2012

Robert L. Osborn
3310 South 725 East
Pierceton, Indiana 46562

Dear Mr. Osborn:  

The Food and Drug Administration (FDA) has completed an evaluation of your corrective actions in response to our Warning Letter (2012-DET-02) dated October 11, 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 subsequent inspection or through other means.

Sincerely, 

/S/

Tina M. Pawlowski
Compliance Officer
Detroit District Office