Inspections, Compliance, Enforcement, and Criminal Investigations
A & D Electronics (Shenzhen) Co., Ltd. - Close Out Letter 8/7/13
Department of Health and Human Services
|Food and Drug Administration|
10903 New Hampshire Avenue
White Oak Building 66
Silver Spring, MD 20993
AUG 07, 2013
A&D Electronics (Shenzhen) Co., Ltd.
Datianyang Industrial Zone
Baoan District, Shenzhen 519105
Dear Mr. Kohara:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #360078 and dated November 13, 2012. 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.
William C. MacFarland
Division of Enforcement B
Office of Compliance
Center for Devices and