FDA Refusing Imports From Two Chinese Pharma Companies
The Food and Drug Administration told two Chinese drug facilities that it plans to refuse admission to their pharmaceutical products, in two warning letters sent in late September. FDA says it found violations of current good manufacturing practice (CGMP) regulations…
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for pharmaceuticals at a China Resources Sanjiu (999) Medical and Pharmaceutical Co., Ltd. located in Shenzhen (here). It also said the facility is unregistered because the company changed locations without amending its registration. As a result, FDA is already refusing shipments of pharmaceuticals from the facility. In a separate letter, FDA notified Beijing Shunxin Meihua Bio-technical Co., Ltd. that it has been placed on three import alerts because it refused or limited an inspection by FDA officials (here). Additionally, from the documents it was able to review, the agency said it found the company is being supplied with crude heparin by another company that is already on an import alert for the pharmaceutical product.