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MANI HANOI CO. LTD Aug 08, 2016

Mani Hanoi Co. LTD - Close Out Letter 8/8/16



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

 Food and Drug Administration
10903 New Hampshire Avenue
White Oak Building 66
Silver Spring, MD 20993

Via United States Postal Service

AUG 08 2016

Masahiko Saito
Director General and President
Mani Hanoi Co. LTD
Tan Huong Commune
Pho Yen District
Thai Nguyen Province

Dear Mr. Saito:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 430222 dated June 11, 2014. 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.



Carl Fischer, Ph.D.
Division of International Compliance
Office of Compliance
Center for Devices and Radiological