- Zhejiang Hisun Pharmaceutical Co., Ltd.
- Issuing Office:
10903 New Hempshire Avenue
Silver Spring, MD 70993
June 1, 2017
Mr. Hua Bai
Chairman and CEO
Zhejiang Hisun Pharmaceutical Co., Ltd.
46 Waisha Road, Jiaojiang District
Taizhou City, Zhejiang. 318000
Reference: FEI 3007719313
Dear Mr. Bai:
The Food and Drug Administration (FDA) has completed an evaluation or your firm's corrective actions in response to our Warning Letter: 320-16-06 dated December 31, 2015. Based on our evaluation, it appears that you have addressed the deviations 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 pertain to CDER/OPQ, CDER/OND, or CDER/OGD decision-making on any pending applications naming this facility and is without prejudice to future decisions by those officcs relating to such applications.
This letter does not relieve you or your firm from 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 FDA expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter wi ll not preclude any future regulatory action should deviations be observed during a subsequent inspection or through other means.
Tamara S. Rosbury, Ph.D.
Division of Drug Quality II