Chinese API Maker Cited for Numerous Violations

During an inspection of Linhai Tianyu’s facility in Taizhou, Zhejiang, the FDA investigators found that the quality unit failed to properly respond to urgent requests from a customer for testing of an API batch and failed to file the requests as complaints.

Similarly, a customer called and reported that Taiwan’s regulator found an impurity in two API batches, but the company did not file the call as a complaint.

The investigators also saw white material falling from the ceiling to the floor near a workshop reactor. The ventilation system also blew air directly towards the reactor.