Chinese API maker spanked in warning letter


Some FDA warning letters are long, drawn-out documents listing specific and multiple violations and sometimes offering a blueprint for fixing issues. Others are short and to the point, essentially saying a drugmaker doesn’t have its manufacturing act together and until it does, the FDA is not going to approve its products for sale in the U.S. China’s Guangzhou Haishi Biological Technology got one of the short ones.

In a letter posted by the FDA this week, it said that it uncovered issues during an inspection in July 2015 at its plant in Guangzhou, Guangdong.

The FDA's three-point explanation of problems said the Chinese company didn’t test finished batches for the identity and strength of active ingredients before shipping them to the U.S. It didn’t conduct a single identity test on a component when relying on that component supplier’s analysis, and it has no written process control procedures to make sure drugs meet standards.

The FDA told Guangzhou Haishi that its response that it will buy testing equipment will not cut it because the API maker still didn’t commit to testing every batch before they are sent to the U.S. The FDA also wants an explanation of the risks that are inherent from the untested products it has already sold in the U.S.

The FDA has placed the company on its import alert list, banning its products from the U.S. It said the drugmaker’s best bet would be to hire a consultant that can help it get its house in order.

The FDA has stepped up inspections of Chinese drugmakers and last week posted two warning letters recently sent to Chinese companies. One of those was to Chongqing Lummy Pharmaceutical, a company that it turns out was producing the API for a chemo drug from Lannett that the FDA recently approved. When the FDA figured out that one part of the agency had approved a product while another was banning the API it was made with from entry into the U.S. because of data integrity issues, it rescinded Lannett’s approval. That led Lannett to sue the FDA, saying its rights had been violated by pulling back the drug approval without even receiving a hearing. 

- here’s the Guangzhou Haishi Biological warning letter

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