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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Zevex International, Inc. - Close Out Letter 11/30/11

  

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

Public Health Service
Food and Drug Administration
 

Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
Telephone: 303-236-3000
         FAX: 303-236-3100

 

November 30,2011

VIA UPS

Mr. Robert T. Brady
CEO and President
MOOG, Inc.
300 Jamison Road
East Aurora, New York 14052

Ref: #DEN-11-11-WL (Zevex International, Inc., 4314 Zevex Park Lane, Salt Lake City, UT)

Dear Mr. Brady:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, DEN-11-11-WL, dated April 20, 2011. Based on our evaluation, it appears that you have 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 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/

LaTonya M. Mitchell
District Director
 

cc: Mr. Martin J. Berardi
     Vice President Medical Group
     MOOG, Inc.
     300 Jamison Road
     East Aurora, New York 14052