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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Bristol Myers-Squibb Company Close out Letter 6/7/11

   

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

 Public Health Service
Food and Drug Administration
  San Juan District
466 Fernandez Juncos Avenue
San Juan PR 00901-3223
Telephone: (787) 474-9500
FAX: (787) 729-6658 

 

June 7, 2011


WARNING LETTER CLOSE OUT LETTER


CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Mr. Lamberto Andreotti
President and CEO
Bristol Myers- Squibb Company
345 Park Avenue
New York, NY 10154


Dear Mr. Andreotti:


The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter SJN-2010-06 dated 08/30/2010. 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,
Kind regards,

/S/

Edwin Ramos 
Director of Compliance
San Juan District Office

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