Missing Audit Trail Review led to Warning Letter

Recommendation

26-28 October 2021

Bioassays and Bioanalytics + Stability Testing for Biological/Biotechnological Drug Substances and Drug Products - Live Online

This FDA Warning Letter issued to pharmaceutical manufacturer Zhejiang Ludao Technology Co., Ltd. on 23 February, 2018 is based on an FDA inspection which took place in August 2017.

It came to light during the inspection that the analytical testing results of four batches of finished products could not be provided.

Furthermore, there were three data files found in the electronic recycle bin of the stand-alone HPLC system which had been used to test a manufactured spray. Since this HPLC system had no Audit Trail capabilities, it could not be said how frequently test data had been deleted before an "official" test result was declared.

The company's response was not sufficient in the eye of the FDA: Zhejiang Ludao Technology conducted no retrospective evaluation of the extent of insufficient data retention. The effect on other electronic systems had not been evaluated, either. The response particularly lacked details on the validation and the Audit Trail Review possibilities of the new HPLC system.

Please also read the complete FDA warning letter to Zhejiang Ludao Technology Co., Ltd..