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  1. Compliance Actions and Activities

CLOSEOUT LETTER

Moringa Nativa


Moringa Nativa

  

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

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

August 3, 2016

16-SJN-WLCOL-02 / CMS # 476959

VIA UNITED PARCEL SERVICE
NEXT DAY-SIGNATURE REQUIRED


Ivette Veiga
Moringa Nativa
PO BOX 7891 PMB 495
Guaynabo, Puerto Rico 00970

Dear Mrs. Veiga:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 16-SJN-WL-04 dated 12/18/2015. 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.


Sincerely yours,

/S/

Edwin Ramos
Director of Compliance Branch
San Juan District