Inspections, Compliance, Enforcement, and Criminal Investigations
Customed, Inc. Close out Letter 9/2/10
| Public Health Service Food and Drug Administration |
466 Fernandez Juncos Avenue |
Department of Health and Human Services
September 2, 2010
CERTIFIED MAIL
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,
/S/
Edwin Ramos
Director of Compliance
San Juan District Office
