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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Alcor Scientific, formerly OST Medical, Inc. - Close Out Letter 7/11/12

  

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
(781) 587-7500
FAX: (781) 587-7556

July 11, 2012

Mr. Carlo Ruggeri
CEO and President
Alcor Scientific, formerly OST Medical, Inc.
11 Knight Street, Building F23
Warwick, RI 02886-1281

Dear Mr. Ruggeri:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter dated January 27, 2010 (NWE -13-10W). Based on our evaluation, it appears that you have addressed the violations contained 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/

Amber G. Wardwell
Director of Compliance
New England District