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  5. Deseo Rebajar - Close Out Letter 7/21/15
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CLOSEOUT LETTER

Deseo Rebajar 21/07/2015

Deseo Rebajar - Close Out Letter 7/21/15


Deseo Rebajar

  

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

Food and Drug Administration
 San Juan District
466 Fernandez Juncos Avenue
San Juan PR 00901-3223
Telephone: (787) 729-8500
         FAX: (787) 729-6658
 

July 21 , 2015


15-SJN-WLCOL-07

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Jose Polanco-Ortiz

Deseo Rebajar Inc.
G35 Calle Pino, Villa Turabo
Caguas, Puerto Rico 00725

Dear Mr. Polanco:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to Warning Letter 14-SJN-WL-02 dated 03/07/2014. 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.


Kind regards,

/S/

Margarita Santiago
Compliance Officer,
San Juan District Office