Data Integrity and Quality Problems Found at China Facility

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FDA sent a warning letter to Shandong Analysis and Test Center for CGMP violations including data integrity issues and insufficient testing procedures.

FDA sent a warning letter, dated June 22, 2017, to Shandong Analysis and Test Center after an inspection found violations of current good manufacturing practice at the company’s 19 Keyuan Road, Jinan, Shandong facility. The deviations mentioned in the letter include a lack of proper testing procedures and a failure to ensure data integrity.

During the inspection, which was conducted Jan. 16–18, 2017, investigators found that the company did not have the proper procedures to establish quality and purity of API product. Specifically, the agency stated in the letter that the company did not “routinely establish system suitability when testing samples for over-sulfated chondroitin sulfate (OSCS).” Testing of system suitability failed, and the failure was not properly investigated.

“In your response, you acknowledge that your laboratory performed system suitability infrequently, noting that ‘the heparin standards (USP) and OSCS were detected at least (b)(4).’ You committed to routinely establish system suitability before analyzing batch samples in the future. Your response is inadequate because you did not investigate the validity of all test results for OSCS in heparin or heparin-related drugs during the period in which you failed to conduct system suitability in coordination with sample analyses,” the agency stated in the letter.


Another problem highlighted by FDA was data integrity. Basic controls to prevent changes and/or omissions to data were not in place. “During our inspection, we requested that you display original electronic data for analysis of heparin and heparin-related drug samples. Your analyst was unable to retrieve requested data, and explained that he deletes older data to make space for newly acquired data,” the agency stated. 

Source: FDA