# FDA 483 - Hans Biomed Corporation - September 12, 2025

Source: https://www.keypedia.com/records/483/hans-biomed-corporation/458ae7eb-fd02-45d4-86b8-c9e5927ff132

> FDA 483 for Hans Biomed Corporation on September 12, 2025. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Hans Biomed Corporation
- Inspection Date: 2025-09-12
- Product Type: biologics
- Office Name: Division of Blood Components and Devices
- Summary: 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.

## Related Documents

- [483 - 2025-09-12](https://www.keypedia.com/records/483/hans-biomed-corporation/d7fcfba7-a9a0-4612-a268-f677eccea34d)

## Related Officers

- [Amy Kim](https://www.keypedia.com/people/amy-kim/eee8b97a-b9d0-4709-96dc-70dbadd3a6a4)

Company: https://www.keypedia.com/companies/hans-biomed-corporation/60abe6f2-149e-4591-8422-7edc574c65a7

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917