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Regulatory Focus™ > News Articles > FDA Warns Chinese API Maker for Data Integrity Issues

FDA Warns Chinese API Maker for Data Integrity Issues

Posted 21 June 2017 | By Michael Mezher 

FDA Warns Chinese API Maker for Data Integrity Issues

The US Food and Drug Administration (FDA) on Monday released a warning letter sent to active pharmaceutical ingredient (API) maker Qinhuangdao Zizhu Pharmaceutical for data integrity issues uncovered during an inspection of its Hebei province facility late last year.


In March, FDA placed Qinhuangdao on import alert as a result of the inspection findings, an action that raised alarms at the World Health Organization (WHO), as the company is the only prequalified API supplier for the emergency contraceptive levonorgestrel. The company is also prequalified by WHO to supply API for two other contraceptives, mifepristone and ethinylestradiol.

According to WHO, its 2015 inspection of Qinhuangdao's facility turned up five major deficiencies, including data integrity issues, though the inspection was "closed as compliant" after the company provided corrective and preventative actions (CAPAs) for the deficiencies.

While WHO notes that it has not received any reports relating to quality issues for levonorgestrel and that procurement agencies can continue to purchase finished drugs that contain APIs made by Qinhuangdao, the agency said it is planning a follow-up inspection of the facility and is looking to identify alternative sources for levonorgestrel API.

FDA Warning Letter

Now, FDA's warning letter sheds light on the issues that prompted the import alert.

According to FDA, Qinhuangdao employees manipulated test results from its high performance liquid chromatography (HPCL) 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," FDA writes, adding that the company only reported passing results from the repeated tests.

FDA also says the company had disabled the audit trail feature on seven of the HPLC systems at the facility.

FDA investigators also say they found batch production records that were missing manufacturing data, dates and signatures. In one instance, the investigators say they found 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.


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