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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Moehs Iberica, S.L. - Close Out Letter 8/14/12

  

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
Office of Manufacturing and Product Quality
Division International Drug Quality
International Compliance Branch
10903 New Hampshire Avenue
Building #51, Room 4237
Silver Spring, MD 20993

 

TELEPHONE: (301) 796-4839
          FAX: (301) 847-8742

August 14, 2012

Mr. Xavier Castellsague
Managing Director
Moehs Iberica, S.L.
Poligono Rubi Sur
Cesar Martinell I Brunet, 12A-08191, Rubi (Barcelona)

Dear Mr. Castellsague:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 320-11-011 dated April 14, 2011. 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 arid 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/

Rafel Arroyo
Office of Compliance
Division International Drug Quality