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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Empresas Y-Nuina, Inc. - Close Out Letter 6/10/14

  

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

 
 Food and Drug Administration
466 Fernandez Juncos Avenue
San Juan, Puerto Rico, 00901
Telephone: 787-729-8500
FAX: 787-729-8826

 

June 10, 2014


14-SJN-WLCOL-03


CERTIFIED MAIL
Return Receipt Requested


Mr. Enrique Mangual Flores
President
Empresas Y-Nuina, Inc.
P.O. Box 1661
Canovanas, PR 00729


Dear Mr. Mangual:

We have completed an evaluation of your firm's corrective actions in response to our Warning Letter 11-SJN-WL-01 dated November 16, 2010. Based on our evaluation, it appears that you have addressed the violations contained in the Warning Letter.

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 provided in the letterhead. You may also contact Mr. Carlos A. Medina, Compliance Officer at telephone number 787-729-8617 or at carlosa.medina@fda.hhs.gov.

 

Kind regards,

/S/

Edwin Ramos
Director of Compliance
San Juan District Office