Customed, Inc - Close Out Letter 12/14/16

December 14, 2016

17-SJN-WLCOL-02

VIA UNITED PARCEL SERVICE
NEXT DAY DELIVERY/SIGNATURE REQUIRED

Mr. Felix B. Santos
President and Owner
Customed Inc.
Calle Igualdad Final #7
Fajardo, Puerto Rico 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 15-SJN-WL-01 dated December 9, 2014. Based on our evaluation during the August 31, 2016 inspection of your firm, 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 yours,
/S/

Edwin Ramos
Director of Compliance
San Juan District Office