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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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CP Pharmaceuticals, Ltd. - Close Out Letter 7/23/12

  

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 of International Drug Quality
International Compliance Team
10903 New Hampshire Avenue
Building #51, Room 4221
Silver Spring, MD 20993
TELEPHONE: (301) 796-3916
FAX: (301) 847-8742

 

July 23,2012

Mr. Sirjiwan Singh
Managing Director
CP Pharmaceuticals, Ltd.
Ash Road North
Wrexham Industrial Estate
Wrexham, LL13 9UF, United Kingdom

Reference: FEI 3003369660

Dear Mr. Singh:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter WL: 320-11-002, dated October 29, 2010. 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/

Maan Abduldayem
Compliance Officer
Division of International Drug Quality