FDA WARNING_LETTER - Beijing Shunxin Meihua Bio-technical Co., Ltd.

On February 19, 2014, the FDA attempted an inspection at Beijing Shunxin Meihua Bio-technical Co., Ltd. in China, a crude heparin manufacturer. The firm limited and/or refused the inspection, barring access to production areas and denying access to requested records, including batch production records. This refusal renders their drugs adulterated under Section 501(j) of the Federal Food, Drug, and Cosmetic Act.

The FDA noted the firm uses a supplier, (b)(4), which shares an address with (b)(4), a company on FDA Import Alert 55-03 for potentially adulterated heparin and inadequate quality systems. This raises concerns about Beijing Shunxin Meihua Bio-technical Co., Ltd.'s supplier qualification and potential for manufacturing adulterated heparin. Furthermore, FDA tests confirmed ruminant DNA in a sample of their porcine crude heparin (batch BB120425) collected from a customer.

Consequently, the firm was placed on Import Alerts 55-03, 66-40, and 99-32 on July 22, 2014. The FDA requires the firm to investigate and correct these violations. Until a full inspection confirming CGMP compliance is permitted, the FDA may withhold approval of new drug applications listing the firm as a manufacturer, and shipments to the U.S. are subject to refusal of admission. A written response is