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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Heartsine Technologies Inc Close Out Letter 5/17/10

   

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

Public Health Service
Food and Drug Administration
  Philadelphia District Office
Central Region
U.S. Customhouse
2nd & Chestnut Sts., Room 900
Philadelphia, PA 19106
Telephone: (215) 597-4390
FAX: (215) 597-5798

 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

 

May 17, 2010

 

Gregory Cash, President & CEO
Heartsine Technologies
131 Friends Lane, Suite 400
Newtown,PA 18940

Dear Mr. Cash:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 10-PHI-02. Based on our evaluation, it appears that you have addressed the violation(s) 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/

Steven L. Carter
Director, Compliance Branch
Philadelphia District OffIce