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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Defibtech, LLC - Close Out Letter 2/2/12

  

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

Public Health Service
Food and Drug Administration
 

New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
Phone: (781) 587-7500
FAX: (781) 587-7556

February 2, 2012

Mr. Gintaras Vaisnys
President
Defibtech, LLC
741 Boston Post Rd, Ste 201
Guilford, CT 06437-2714

Dear Mr. Vaisnys:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter NWE-22-10W, dated September 22, 2010. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Also, based upon this evaluation, it is unnecessary to submit to the agency a certification by an outside expert by September 21, 2012 as previously requested in the 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/

Todd Maushart
Compliance Officer
New England District