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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Customed, Inc. Close out Letter 9/2/10


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

Public Health Service
Food and Drug Administration

466 Fernandez Juncos Avenue
San Juan, Puerto Rico, 00901
Telephone: 787-474-9500
FAX: 787-729-6658 

September 2, 2010

Return Receipt Requested

Mr. Felix B. Santos
Owner and President
Customed, Inc.
Calle Igualdad Final #7
Fajardo, P.R. 00738

Dear Mr. Santos:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter SJN-2009-10 dated September 11, 2009. 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.

Should you have questions and/or comments regarding this matter, please feel free to contact me at the district office address provide above in the letterhead. You may also contact Mr. Carlos A. Medina, Compliance Officer at telephone number 787-474-9538 or at carlosa.medina@fda.hhs.gov.

Kind regards,
Edwin Ramos
Director of Compliance
San Juan District Office