Data Integrity Failures and Other CGMP Violations Found at China Facility

April 30, 2018

FDA sent a warning letter to Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. for failure to follow current good manufacturing practices.

An FDA warning letter, dated April 19, 2018, was sent to Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. in response to an inspection performed at the company’s Nankou Industrial Park, Lijiang, Yunnan facility that found a variety of deviations from current good manufacturing practices (CGMPs). The inspection, which was performed by FDA officials from Oct. 16–20, 2017, found deviations cited by the agency in previous inspections.

According to the letter, inspectors found the company had failed to have sufficient controls over computerized systems. After an FDA inspection conducted in 2015, the company had committed to enhancing its data integrity, but during the recent inspection, officials found that the company had not implemented the plans as promised. Inspectors also found data “deleted by accident.” FDA stated that the company’s response to the findings was insufficient: “you did not include evidence to support recovery of deleted electronic data or demonstrate how you will prevent such deletions from recurring in the future.”

Additional CGMP violations included “failure to document, explain, and investigate any deviation from established procedures and failure of [the] quality unit to review and approve all appropriate quality-related documents.”

The agency requested that the company perform a comprehensive investigation into data recording inaccuracies, a current risk assessment of the potential effects of observed failures on products, and a management strategy for corrective action and preventive action plans.

“In a previous FDA inspection of March 30 to April 3, 2015, FDA cited numerous similar CGMP deviations. You proposed specific remediation for these deviations in your response. Our current inspection identified multiple failures to implement your specific corrective actions. These repeated failures demonstrate that your facility’s oversight and control over the manufacture of drug products is inadequate. Explain how you intend to assure your commitments are fulfilled and corrective actions are completed,” the agency stated in the letter. FDA placed the firm on Import Alert 66-40 on Feb. 8, 2018.

Source: FDA