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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Merck KGaA - Close Out Letter 3/18/14

  

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 of International Drug Quality
10903 New Hampshire Avenue
Building #51, Room 4223
Silver Spring, MD 20993

TELEPHONE: (240) 402-4179
FAX: (301) 847-8742

 

March 18, 2014


Dr. Karl-Ludwig Kley
Chairman of the Executive Board and General Partner
Merck KGaA,
Frankfurter Str. 250
64293 Darmstadt
Germany


References: FEI# 3003131678
                        FEI# 3002807447
                        FEI# 3002807252


 

 

Dear Dr. Kley:

The Food and Drug Administration has completed the evaluation of your firm’s corrective actions in response to our Warning Letter WL # 320-12-06 dated December 15, 2011. 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,


/Xiaohui Shen/
Xiaohui Shen
Compliance Officer
Division of International Drug Quality
CDER / OC / OMPQ