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U.S. Department of Health and Human Services

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Enforcement Actions

Siemens Healthcare Diagnostics, Inc. - Close Out Letter 1/28/13

  

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

Public Health Service
Food and Drug Administration
 PHILADELPHIA DISTRICT
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106

Telephone: 215-597-4390

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

 


January 28, 2013

 


Mr. Edward Leonard
Vice President, Global Logistics/Site Leader
Siemens Healthcare Diagnostics, Inc.
700 GBC Drive
Newark, DE 19702


Dear Mr. Leonard:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 12-PHI-18, issued June 29, 2012. 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/

Steven L. Carter
Director, Compliance Branch
Philadelphia District Office