483
Hans Biomed CorporationFDA 483 - Hans Biomed Corporation - September 12, 2025
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Record Details
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.
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