A Chinese API maker that was put on the FDA’s import alert list in March has now been given a warning letter outlining data integrity issues that raise questions about the quality of its drugs.
The letter was issued June 12 to Henan Lihua Pharmaceutical, which specializes in production of corticosteroids APIs and related intermediates. The citation followed inspections of the company’s two plants in Anyang late last year.
What concerned FDA inspectors was the fact that the company’s quality control unit was not approving the release of all of the company’s products, and the fact that it didn't have control over some of its documents. In addition to that, the company was not keeping a complete audit trail of its analytical testing.
The FDA noted that that Henan Lihua Pharmaceutical “committed to using a consultant to assist in meeting FDA requirements,” then gave the drugmaker a long list of improvements in data integrity that must be made if it wants to free itself from the import alert.
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Data integrity has become a big consideration of the FDA, which has often found foreign drugmakers falsifying testing data that show their drugs are safe.