FDA 483 - Hanlim Pharm Co., Ltd. - April 24, 2026

Hanlim Pharm Co., Ltd., an OTC sterile drug manufacturer in Yonginsi, Korea, was cited for numerous significant deficiencies during an FDA inspection from April 16-24, 2026. The observations highlight severe issues in aseptic processing, including poor practices, inadequate validation, and environmental monitoring, many of which were repeat findings. Additionally, the firm failed to properly utilize stability data for expiration dates, maintain equipment, ensure data integrity, and validate analytical methods, indicating systemic quality control and manufacturing control failures.