Zhejiang Biomet Medical Products Co. Ltd. - Close Out Letter 5/8/17
- Zhejiang Biomet Medical Products Co. Ltd.
10903 New Hampshire Avenue
Silver Spring, MD 20993
MAY 8, 2017
Via United States Postal Service
General Manager, Senior Operations Director - Asian Operations
Zhej iang Biomet Medical Products Co. Ltd.
980 Shenli Road, Jinhua
Dear Mr. Wang:
The Food and Drug Administration (FDA) has completed an evaluation of your finn's corrective actions in response to the Warning Letter dated June 3, 2015. Based on the Agency's evaluation, it appears that your firm has 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 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 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.
Ronald L. Swann, M.S.
Division of International Compliance Operations
Office of Compliance
Center for Devices and Radiological Health