China Facility Receives FDA Warning Letter

FDA sent a warning letter, dated March 18, 2019, to Dong Yuan Technology Co., Ltd. after an inspection of the company’s Shandong Province, China facility found violations of current manufacturing good practices (CGMP). The inspection, conducted from Sept. 24–28, 2018, found that the company was not establishing or following proper laboratory and process controls.

Specifically, FDA stated in the letter that the company was not using US Pharmacopeial Convention (USP)-equivalent laboratory assay methods for some products. In addition, samples of some products were not tested. FDA requested the company commit to using USP compendial methods, provide the agency with findings and deviations from assay test methods, provide a procedure for documenting and investigating deviations from laboratory controls, and test results using a validated test method.

The agency also stated that the company’s process validation program was inadequate. FDA asked the company to provide a validation plan for ensuring a state of control and actions the company plans to take to ensure the quality of its drug products that will be distributed to the US market.

Data integrity problems were also detailed in the letter. “You do not retain laboratory data generated by your analysts. During our inspection, your staff told our investigator that your firm’s laboratory worksheets contain only final laboratory results. You do not retain records of sample weights written on paper. The papers are discarded after your staff performs calculations.

Due to your failure to retain laboratory data, our investigator was unable to confirm the validity of your results. You could not provide any rationale for failing to maintain the complete data. Your staff further stated to our investigator that if a sample preparation is not good, it is thrown away and restarted. The staff does not retain that data,” the agency stated in the letter.

FDA recommended the company retain a consultant to assist in remediation of its data integrity problems. The agency requested the company provide an investigation into data records and reporting inaccuracies, a risk assessment for the potential effects of quality failures, and a management strategy for corrective actions and preventive actions.

Source: FDA