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CLOSEOUT LETTER

He Gao Plastic Factory


He Gao Plastic Factory

  

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

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

DEC 27, 2016

Kai Ping Chan
Owner
He Gao Plastic Factory
Block A, 12/F, Gee Luen Factory Building
316-318 Kwun Tong Road
KOWLOON
HONG KONG
CHINA

Dear Mr. Chan:

The Food and Drug Administration (FDA) has completed an evaluation of your firm 's corrective actions in response to our Warning Letter (CMS # 276757, dated March 20, 2012). Based on our evaluation, it appears that your firm has addressed the violations contained in the 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/
Matthew Krueger, M.S.E.
Acting Director for Division of International
Compliance Operations
Office of Compliance
Center for Devices and Radiological Health
 

cc:
US Agent:
Julia Costello
Kids II , Inc.
3333 Piedmont Rd. , Suite 1800
Atlanta, GA 30305