U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Hong Ngoc PTE - Close Out Letter 8/1/17
  1. Compliance Actions and Activities


HONG NGOC PTE 01/08/2017

Hong Ngoc PTE - Close Out Letter 8/1/17




Black HHS-Blue FDA Logo


5001 Campus Drive
College Park, MD 20740 


August 1, 2017

Mr. Tran Thi
Lot B3, Hoa Hiep Industrial Zone
Hoa Hiep Bac Commune, Dong Hoa Village
Phu Yen, VN-32 VN


Dear Mr. Thi,

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions following issuance of our Warning Letter #408274, issued November 7, 2013. Based on our evaluation, it appears you have addressed the violations contained in the 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.


Mildred P. Benjamin
Branch Chief
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition