FDA issues warning letter Hisun’s API plant in China

FDA issues warning letter to Hisun’s API plant in China

11:07 AM, 18th January 2016
FDA issues warning letter to Hisun’s API plant in China
The headquarters of the US Food and Drug Administration is shown in Silver Spring near Washington. © CNN (File photo)

SILVER SPRING, US: The US Food and Drug Administration (FDA) said that it has warned China-based Zhejiang Hisun Pharmaceutical, which established a joint venture with Pfizer in 2012, for data integrity violations more than three months after banning the company’s products from entering the US.

During March 2015, investigators from the FDA inspected the drug manufacturing facility and identified significant deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical ingredients (API).

These deviations caused the drugs to be adulterated in the methods used for their manufacture, processing, packing or holding do not conform to, or are not operated or administered in conformity with, CGMP, said FDA.

The investigators observed specific deviations during the inspection, including the following:

1.    Failure to prevent unauthorized access or changes to data, and to provide adequate controls to prevent manipulation and omission of data.

2.    Failure to conduct appropriate microbiological testing on API batches where microbial quality is specified.

“Our investigators found that the firm routinely re-tested samples without justification and deleted analytical data. We observed systemic data manipulation across the facility, including actions taken by multiple analysts, on multiple pieces of testing equipment, and for multiple drugs. They are responsible for determining the causes of these deviations, for preventing recurrence, and for preventing other deviations from CGMP,” FDA said.

The warning letter was issued because the audit trail was disabled. All supporting raw data was discarded, including sample solution dilutions and balance weight printouts. Sample analyses were not recorded in the instrument use logbook. Test results were deleted from the hard drive and all supporting chromatograms were discarded.

The investigator later discovered the missing data in a backup folder.

The FDA has asked the Chinese API manufacturer to submit a timeline for completing retroactive microbial testing of all potentially-compromised batches via an independent laboratory and also plans for corrective and preventive action management procedure in the future. 

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