FDA outlines data integrity problems with Chinese API maker under import ban

The FDA said Qinhuangdao Zizhu employees manipulated test results from its high-performance liquid chromatography systems by overwriting test results and running repeat tests until the desired results were achieved.

The FDA released a warning letter sent to Chinese API maker Qinhuangdao Zizhu Pharmaceutical in April that outlined data integrity problems at the company’s Hebei province facility following an inspection late last year.

The regulatory agency placed an import alert on Qinhuangdao Zizhu in March. That action left the World Health Organization scrambling to find another company to supply the ingredient for the birth control drug levonorgestrel. The company was the only WHO prequalified API supplier for levonorgestrel. It was also prequalified by WHO to supply API for the contraceptives mifepristone and ethinylestradiol.

In its letter, the FDA said Qinhuangdao Zizhu employees manipulated test results from its high-performance liquid chromatography systems by overwriting test results and running repeat tests until the desired results were achieved.

"During the inspection your analysts admitted to setting the clock back and repeating analyses for undocumented reasons," the agency said. Additionally, inspectors found that the company only reported passing results from the repeated tests.

Inspectors also found that the company had disabled the audit trail feature on seven of the HPLC systems at the facility.

In one instance, inspectors uncovered sticky notes from the company's quality assurance department on batch records that instructed operators to fill in the missing data for a batch of starting material that ultimately went on to be used in manufacturing without being approved by the quality unit.

In March, the WHO announced that while it would look for other med makers to supply the API for the contraceptives it asked suppliers of the finished tablets to continue to produce them with the API from Qinhuangdao Zizhu but for them to conduct additional testing to assure their quality.