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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Sutures India Pvt. Ltd. - Close Out Letter 5/10/13

  

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

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

 

MAY 10, 2013


Mr. L.G. Chandrasekhar
Chairman
Sutures India Pvy. Ltd.
472 D, 13th Cross, 4th Phase
Peenya Industrial Area
Bangalore, Karnataka, India


Dear Mr. Chandrasekhar:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter dated September 3, 2010. Based on our evaluation, it appears that your firm has 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 FDA 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 yours,

/S/

Steven D. Silverman
Director
Office of Compliance
Center for Devices and
  Radiological Health

 

cc:  Thomas Becze, President
      Princeton Regulatory Associates, LLC
      116 Village Boulevard, Suite 200
      Princeton, NJ 08540