FDA 483 - Hanlim Pharm Co., Ltd. - May 31, 2022

An FDA inspection of Hanlim Pharm Co., Ltd., a drug manufacturer based in Yonginsi, Gyeonggi-do, Korea, was conducted from May 23 to May 31, 2022. The inspection highlighted critical deficiencies in the firm's electronic data management and integrity practices. Key observations included the failure to adequately check the accuracy of electronic data, specifically noting that the data review process for chromatographic analyses (HPLC & GC) did not include an examination of audit trail histories. This oversight raises concerns about the reliability of analytical data.

Additionally, the inspection identified a significant lack of data backup for critical electronic records. The company uses an Excel spreadsheet to track and reconcile logbooks for manufacturing operations, but this system does not comply with 21 CFR Part 11 requirements for electronic records, as it lacks essential audit trail features. Moreover, this vital spreadsheet file is stored on a standalone computer without any backup, exposing the data to a high risk of loss and compromising its integrity.

These observations underscore the urgent need for Hanlim Pharm Co., Ltd. to implement robust corrective actions. The firm must establish comprehensive data review processes that incorporate audit trail verification and ensure all electronic records pertinent to manufacturing operations meet regulatory standards for integrity, security, and reliable backup systems. Addressing these issues is paramount for maintaining regulatory compliance and ensuring the quality and trustworthiness of their drug products.