News
Industry News
CFDA suspended the import of Cefmetazole Sodium for injection from South Korean Daewoong Pharmaceutical Co., Ltd due to its rejection of inspection
Date:2016-10-14

Recently CFDA had issued a notice to each Port FDA to suspend the import of Cefmetazole Sodium for injection from South Korean Daewoong Pharmaceutical Co., Ltd.

In order to strengthen the management of imported drugs, CFDA intended to inspect the work site of some of the imported drugs according to its annual inspection plan, which includes the work site of Cefmetazole Sodium for injection from South Korean Daewoong Pharmaceutical Co., Ltd. However, Daewoong company didn’t accept the planned inspection. So CFDA decided to suspend the import of Cefmetazole Sodium for injection from Daewoong till the complete of inspection and confirm of compliance with Chinese GMP requirements.

GMP is a legal technical specification which is generally applied in the world for the supervision of whole process of drug manufacturing and is the reliable measurement to ensure the drug quality and safety. CFDA emphasized that the manufacturing of drugs which are sold in China should be complied with the Chinese GMP requirements and should be supervised under the Drug Supervision and Administration Department. For those who rejected the regulated inspection or who didn’t comply with the GMP requirements will be severely dealt with according to the laws.

【Back】

Copyright © 2013 China Chinopharma Ltd. All rights reserved.