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Regulatory Focus™ > News Articles > FDA Warns China API Manufacturer for Data Integrity Violations

FDA Warns China API Manufacturer for Data Integrity Violations

Posted 01 March 2017 | By Michael Mezher 

FDA Warns China API Manufacturer for Data Integrity Violations

The US Food and Drug Administration (FDA) in late February warned Fosun Pharmaceutical subsidiary, the formerly Chinese state-owned Chongqing Pharmaceutical Research Institute (CPRI), over data integrity issues.

The warning letter comes after a four-day inspection of CPRI's active pharmaceutical ingredient (API) and contract research and manufacturing facility in Chongqing, China last May.

During the inspection, FDA says it found evidence the company was habitually deleting failed test results in order to meet batch release specifications.

According to FDA, audit trails from CPRI's laboratory equipment revealed that the company had deleted sequences from their high performance liquid chromatography (HPLC) and gas chromatography (GC) analyses.

"The audit trail showed that the final standard injection was permanently deleted from the instrument's computer. Your analyst told our investigator that it is laboratory practice to perform more injections than are required by the procedure, and then delete any undesirable results to ensure passing sustainability tests," FDA writes.

In light of this practice, FDA says the company's quality system does not adequately ensure the accuracy or integrity of the data demonstrating the safety, effectiveness or quality of the drugs manufactured at CPRI's facility.

As a result, the agency is calling on the company to conduct an investigation into its data records and reporting practices and perform a risk assessment on the potential impact on its products.

Data integrity has been a growing area of focus for FDA. In recent years an increasing number of warning letters and Form 483s issued to establishments, primarily in China and India, include citations for data integrity issues. In April 2016, FDA released a draft guidance detailing its expectations and best practices for complying with data integrity requirements.



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