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FDA cited the facility for violations of quality management and data integrity CGMPs.
FDA sent a warning letter, dated May 11, 2017, to Changzhou Jintan Qianyao Pharmaceutical Raw Material Factory following an inspection of the company’s Changzhou, Jintan facility from Feb. 13–17, 2017. The warning letter describes deviations in current good manufacturing practices (CGMPs) including the management of quality and data integrity.
According to FDA, the company failed to implement a comprehensive quality management system to ensure the quality and purity of its API. “Before August 2016, your firm did not have any quality-related procedures in place even though you were manufacturing and shipping drugs to the United States. Although you had drafted some procedures by the time of our February 2017 inspection, you had not yet implemented any such procedures as of the date of our inspection,” FDA stated in the letter.
Written procedures for testing and sampling of incoming materials were also not found by investigators. “Instead, you explained, your warehouse employees accounted for incoming raw material handling, sampling, and testing ‘in their heads’,” the letter stated.
Data integrity was also lacking. The company failed to include complete data in laboratory control records. Investigators found that samples were retested without documentation or investigation and only the final results were reported. Batch production records were also incomplete. “Our investigator found that your operator used process parameter values from previous batches of (b)(4) to complete new batch records when she was too tired to immediately record the data and had forgotten the values,” the agency stated.
The agency recommended the company review FDA and International Council for Harmonization guidance on GMPs for API and hire a CGMP consultant. FDA placed the facility on Import Alert 66-40 on May 4, 2017. “Until you correct all deviations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer,” the agency stated in the letter.