Data Integrity Issues Found at China Facility

June 27, 2018

FDA sent a warning letter to Henan Lihua Pharmaceutical Co. Ltd. after inspectors found the company failed to ensure the accuracy of its data.

FDA sent a warning letter, dated June 12, 2018, to Henan Lihua Pharmaceutical Co. Ltd. following an inspection of the company’s manufacturing facilities in Henan, China. The inspection was conducted from Dec. 11–14, 2017, and inspectors found deviations from current good manufacturing practices (CGMP) associated with data integrity.

The agency stated in the letter that the company failed to review and approve quality-related documents. Blank batch manufacturing records and record issuance stamps were observed in the workshop office.

“These blank records and stamps were uncontrolled, although your standard operating procedure states that your quality unit is responsible for release of blank CGMP records. Your quality unit failed to control these records to assure that information entered on these forms is accurate and reliable. The use of uncontrolled records without quality unit review and approval poses a risk to data integrity and adequate assurance of product quality. FDA recommends that, if used, blank forms be controlled by the quality unit or by another document control method,” FDA stated.

The company also failed to maintain complete laboratory test data, according to FDA. “It is essential to retain raw data to ensure the ability to reconstruct CGMP activities and to review raw data, as necessary, for CGMP control testing,” the agency stated. In response to FDA, the company plans to replace instruments and software. The agency, however, stated in the warning letter that the company must also implement appropriate procedures and systems to ensure that data are retained.

FDA asked that the company provide the agency with a comprehensive investigation into the inaccuracies in data records and reporting, a risk assessment of the potential effects of the data failures on product quality, and a management strategy that includes corrective actions and preventive actions.

The agency placed the company on Import Alert 66-40 on March 29, 2018 and advised the company that approval of new applications or supplements that list the firm as a drug manufacturer may be withheld.

Source: FDA