China API Facility Receives FDA Warning Letter

March 7, 2017

The agency sent a warning letter to Chongqing Pharma Research Institute Co., Ltd. citing data integrity violations.

FDA sent a warning letter to Chongqing Pharma Research Institute Co., Ltd. on Feb. 14, 2017 that summarized current good manufacturing practice (CGMP) deficiencies found at the company’s Chongqing facility during an inspection conducted from May 16–19, 2016. Inspectors found data integrity problems including failure to maintain laboratory testing data.

During the May 2016 inspection, FDA investigators found audit trails that showed the company had deleted chromatographic sequences and individual injections from computers and repeated analyses until acceptable results were maintained. Out-of-specification results were not investigated and only passing results were documented. “You relied on these manipulated test results and incomplete records to support batch release decisions,” the agency stated in the letter.

FDA requested that the company perform data integrity remediation and provide the agency with a comprehensive investigation of the data and reporting inaccuracies; a risk assessment of the potential effects of observed failures on the quality of product; and a management strategy that details a corrective action and preventive action plan.

Source: FDA