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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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Scotty's Inc. Close out Letter 5/12/11

   

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
FAX: 313-393-8139 

 

May 12, 2011


Sandra J. Jackson, Co-Owner
Scotty's, Inc.
3426 Junction Street
Detroit, Michigan 48210-3006


Dear Ms. Jackson,
 

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter, 2010-DT-02, dated November 9, 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 actions should violations be observed during a subsequent inspection or through other means.


Sincerely,
/S/
Glenn T. Bass
Acting District Director
Detroit District Office

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