Inspections, Compliance, Enforcement, and Criminal Investigations
Empresas Y-Nuina, Inc. - Close Out Letter 6/10/14
Department of Health and Human Services
|Food and Drug Administration|
466 Fernandez Juncos Avenue
San Juan, Puerto Rico, 00901
June 10, 2014
Return Receipt Requested
Mr. Enrique Mangual Flores
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 email@example.com.
Director of Compliance
San Juan District Office