On arrival for a pre-approval inspection for a Chinese heparin API maker, an FDA inspector was told that the plant had not started making products and was only doing equipment testing. The truth of the matter was hidden in a drum being snuck out the back. An intercepted container an employee was removing from the warehouse contained two batches of crude heparin manufactured two days earlier.
That was just the beginning of the problems found during July 2019 inspection of Yibin Lihao Bio-technical, the API maker in Yibin Shi Sichuan, China. According to a warning letter, there were quality assurance records scattered in cabinets, on desks and on the floor of the QA office. Employees insisted they were for a grant application from the government and not manufactured products. Not true. The FDA would learn the records did correspond to manufactured heparin.
The FDA last month placed Lihao Bio-technical on import alert, banning its crude heparin and other products from the U.S., in part because its “system for managing quality is inadequate and calls into question the traceability of all drugs, including crude heparin manufactured at your facility.”
Traceability of crude heparin and its raw ingredients has been a big issue at the FDA for a decade after it was whiplashed by Congressional leaders over tainted Chinese heparin in the U.S. supply used to make the finished blood thinner. The investigation began after heparin batches were tied to hundreds of allergic reactions, some fatal.
More recently, Congress has been concerned over the U.S. getting adequate supplies of heparin. Crude heparin is made from pig intestines and China’s swine herds have been devastated by disease. Adding to that is the chance of supply interruptions from COVID-19
Yibin Lihao Bio-technical won’t be supplying any heparin API any time soon. In addition to banning its products, the FDA ordered the manufacturer to get its record-keeping in order and provide the FDA with a comprehensive investigation into the inaccuracies in its data reporting and the potential risks to patients from the drugs the firm has distributed to the U.S.
Feb 26, 2020