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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Z-Medica, LLC Close Out Letter 3/1/10

   

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) 596-7700
FAX: (781) 596-7896

March 1, 2010

Mr. Brian J. Herrman
Chief Executive Officer
Z-Medica, LLC
4 Fairfield Boulevard
Wallingford, Connecticut 06492

Dear Mr. Herrman:

The Food and Drug Administration conducted an inspection at your Wallingford, CT facility on January 26, 2010 to February 2, 2010. The purpose of this inspection was to verify corrective actions in response to our Warning Letter NWE-09-10W dated December 3, 2009. At the conclusion of this inspection you were issued a FDA-483, List of Inspectional Observations dated February 2, 2010. We acknowledge receipt of your letter of February 22, 2010 and find that the corrective actions which you propose, once they are fully implemented, should adequately address the observations made by our investigator.

Based on our evaluation of this inspection and your response to the FDA-483, Inspectional Observations, it appears that you have addressed the violations contained in Warning Letter NWE-09-10W. 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/

Lori A. Holmquist
Compliance Officer
New England District Office
Augusta Maine Resident Post