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CLOSEOUT LETTER

Yoli, Inc d/b/a Mi Constenita


Yoli, Inc d/b/a Mi Constenita

  

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

Food and Drug Administration
 Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone: 312-353-5863

 

May 6, 2014


Mr. Jose B. Dominguez
President
Yoli, Inc d/b/a Mi Constenita
7647 South Kedzie Avenue
Chicago, Illinois 60652


Dear Mr. Dominguez:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, CHI-9-13 dated March 12, 2013. Based on our evaluation, it appears that you have addressed the violation(s) 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,

/S/

Scott J. MacIntire
District Director