CLOSEOUT LETTER
Master And Frank Enterprise. Co., Ltd.
- Recipient:
- Master And Frank Enterprise. Co., Ltd.
United States
- Issuing Office:
United States
| Public Health Service Food and Drug Administration |
| 10903 New Hampshire Avenue Silver Spring, MD 20993 |
Department of Health and Human ServicesFEB 9, 2017
Via United Parcel Service
Gallas Huang
Plant Manager
Master & Frank Enterprises Company
No.17 BanHu Road
HuangJiang Town, DongGuan City
523697 Guangdong
China
Dear Mr. Huang:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter 481365, dated October 27, 2015. Based on our evaluation, it appears that you have addressed the violation(s) 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,
/S/
Matthew Krueger, M.S.E.
Acting Director
Division of International Compliance
Operations
Office of Compliance
Center for Devices and Radiological Health