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CLOSEOUT LETTER

C.P.M Contract Pharma GMBH & Co. KG Jan 14, 2014

C.P.M Contract Pharma GMBH & Co. KG - Close Out Letter 1/14/14


C.P.M Contract Pharma GMBH & Co. KG

  

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

 
 Food and Drug Administration
Silver Spring, MD 20993

 

January 14, 2014


Dr. Uwe Reimers
Head of Production
C.P.M Contract Pharma GMBH & Co. KG
Fruhingstrasse 7
Feldkirchen- Westerham, Germany 83620


Dear Dr. Reimer:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter# GDUFA-13-001 September 17, 2013. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections or 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/

Michael Levy
Deputy Director for Policy and Analysis
Office of Compliance
Center for Drug Evaluation and Research