FDA warns Chinese API maker for trying to hide batches of heparin

When an FDA inspector performed a walkthrough inspection of Yibin Lihao Bio-technical’s facility last year, the agency had been told that the company had not produced any products for months. But then the inspector noticed an employee leaving the warehouse with a fiber drum. After asking about the drum, the inspector was told it contained bags — but after taking a closer look, the inspector found two batches of crude heparin manufactured just days before. 

According to an FDA warning letter issued this month, Lihao, located in China, had no testing records to accompany the errant heparin batches. The agency warned Lihao for its failure to prepare control and production records, and for several failures in quality control.

“During the walkthrough on July 31, 2019, our investigator observed numerous records on the floor, desks, and cabinets of the Quality Assurance (QA) Office on the third floor of the office building. Some of these records included batch production records for heparin,” the agency stated in its warning letter. 

In addition to the warning letter, the FDA banned crude heparin from Lihao on January 15 amid concerns related to the company’s record keeping and quality management.

The agency has remained on high alert for quality deviations in crude heparin sourced from China since 2007 and 2008, when contaminated batches of heparin, a blood thinner, killed more than 100 people in the U.S.