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

Hanlim Pharm Co., Ltd. in Yonginsi, Korea, a drug manufacturer, was inspected by the FDA, revealing significant deficiencies in its electronic data management and control systems. The firm failed to adequately check electronic data for accuracy, specifically regarding chromatographic analyses. Additionally, critical electronic records, such as an Excel spreadsheet for manufacturing logbooks, lacked proper audit trails and backup, failing to meet 21 CFR Part 11 compliance.