US FDA slams Chinese API maker over data breaches
In April, the US Food and Drug Administration (FDA) issued an import alert, banning Qinhuangdao Zizhu Pharmaceutical from supplying drug actives made at its plant in Hebei, China.
And this week the Agency published details of GMP violations from the facility, following an inspection in November and December last year.
The firm failed to prevent unauthorized access and changes to data, and failed to provide adequate controls to prevent omission of data, the FDA stated in a warning letter.
“Our review of audit trail data revealed that your analysts manipulated the date/time settings on your high performance liquid chromatography (HPLC) systems,” the Agency wrote.
“During the inspection your analysts admitted to setting the clock back and repeating analyses for undocumented reasons. Initial sample results were overwritten or deleted, and unavailable for our investigators’ review.”
Furthermore, seven HPLC systems used for API testing had the audit trail feature disabled, despite having audit trail functionality.
Inspectors also found Qinhuangdao Zizhu failed to maintain complete data for all laboratory analyses, and relied on incomplete information to determine whether drugs met established specifications.
“HPLC chromatograms were deleted and not available for our investigators’ review,” the Agecy said, adding there was a “recurring practice of re-testing samples until acceptable results were obtained.”
The company was further criticised for quality unit failings:
“Our investigators found batch production records that contained blank or partially completed manufacturing data and lacked dates and signatures for verification. For example, in your (b)(4) plant, our investigators found a batch record for (b)(4) starting material, batch (b)(4), with sticky notes from the quality assurance department directing operators to enter manufacturing data, such as missing weight and volume entries. Also, your quality unit did not approve this batch record before the material was used in further manufacturing.”
WHO concerns
April’s US import alert also raised concern at the World Health Organisation (WHO) because the Qinhuangdao site is the only source of the hormone levonorgestrel used in two contraceptive products used in its programmes.
At the time, the WHO said procurement agencies can continue to buy contraceptives containing levonorgestrel supplied by Qinhuangdao due to a lack of an alternative source, but urged drug manufacturers to implement additional testing procedures on receipt.
