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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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Zach System S.A. - Close Out Letter 4/12/11

  

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

Public Health Service
Food and Drug Administration
 

CENTER FOR DRUG EVALUATION AND RESEARCH
Division of Manufacturing and Product Quality
International Compliance Branch
10903 New Hampshire Avenue
Bldg. 51, Room #4240
Silver Spring, MD 20993

TELEPHONE: (301) 796-3201
FAX: (301) 847-8742

12 April 2011

Mr. Andre Edern, Deputy General Manager
ZaCh System S.A.
Zone Industrielle La Croix Cadeau B.P. 10079
Avrille Cedex 49242
France

Dear Mr. Edern:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #320-09-12, dated 10/23/2009. 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/

Douglas A. Campbell
Compliance Officer
International Compliance Branch

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