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  5. SmithKline Beecham (Cork) Ltd. - Close Out Letter 8/20/15
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CLOSEOUT LETTER

SmithKline Beecham (Cork) Ltd.


SmithKline Beecham (Cork) Ltd.

  

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 Quality
Division Drug Quality II
Global Compliance Branch 4
10903 New Hampshire Avenue
Building #51 , Room 4243
Silver Spring, MD 20993

TELEPHONE: (301) 796-3208
              FAX: (301) 847-8742

August 20, 2015

Joseph J. Power, Site Director
SmithKline Beecham (Cork) Ltd.
Currabinny
Carrigaline, Co. Cork, Ireland

Reference: FEI 1000170338

Dear Mr. Power:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter WL 320-14-06. 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,

/S/

Tracie H. Sharp
Operations Research Analyst
Division of Drug Quality II
CDER/OC/OMQ