- Jiangsu Province Jianerkang Medical Dressing Co., Ltd.
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
CENTER FOR DRUG EVALUATION AND RESEARCH
|Office of Manufacturing and Product Quality|
Division International Drug Quality
International Compliance Branch
10903 New Hampshire Avenue
Building #51, Room 4235
Silver Spring, MD 20993
TELEPHONE: (301) 796-4839
FAX: (301) 847-8742
November 6, 2014
Mr. Chen Guoping
Jiangsu Province Jianerkang Medical Dressing Co., Ltd.
Zhixi Town, Jintan City, Jiangsu, 213251
Phone: 86 5192441878
Reference: FEI 3006403682
Dear Mr. Guoping:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-12-02 issued on July 20, 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.
Division of International Drug Quality