FDA 483 - Hans Biomed Corporation - September 12, 2025

An FDA inspection of Hans Biomed Corporation, a tissue processor in Youseong-gu, DAEJEON, Korea, identified significant inaccuracies in the firm's records. The observations detailed discrepancies in batch record completion times for a critical processing step and inconsistencies in cleaning records for equipment, including mismatched dates, record numbers, and donor IDs. These findings indicate a failure to maintain accurate and consistent documentation.