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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Impact Instrumentation, Inc. - Close Out Letter 01/09/2013

  

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

Public Health Service
Food and Drug Administration
 Central Region
Waterview Corporate Center
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054

Telephone (973) 331-4902

 

January 9, 2013

 

VIA United Parcel Service

 

Leslie H. Sherman
President
Impact Instrumentation, Inc.
27 Fairfield Place
West Caldwell, NJ 07006


Dear Mr. Sherman:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter Number 10-NWJ-18, dated September 30, 2010. Based on our evaluation, it appears that you have addressed the violation(s) 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/

CAPT Joseph F. McGinnis
Director, Compliance Branch
New Jersey District