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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Portal Pharmaceutical Inc. - Close Out Letter 7/6/10

  

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
 

10-SJN-CRL-09

July 6, 2010

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

 

Mr. Jesus G. Portal Martinez
President
Portal Pharmaceuticals, Inc.
Calle Mendez Vigo #67 Este
Mayaguez, PR 00680

Dear Mr. Portal:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter SJN-2010-02 dated February 2, 2010. Based on our evaluation, it appears that you have addressed the violation 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.


Kind regards,

 

Edwin Ramos
Director of Compliance
San Juan District Office

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