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

Source: https://www.globalkeysolutions.net/records/483/hans-biomed-corporation/d7fcfba7-a9a0-4612-a268-f677eccea34d

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

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## Details

- Record Type: 483
- Company Name: Hans Biomed Corporation
- Inspection Date: 2025-09-12
- Product Type: other
- Office Name: Office of Inspections and Investigations
- Summary: Hans Biomed Corporation, a tissue processor in Youseong-gu, DAEJEON, Korea, was inspected by the FDA. The inspection revealed significant inaccuracies in the firm's records, including discrepancies in batch processing times and inconsistent cleaning records for equipment. These findings indicate serious issues with data integrity and record-keeping practices.

## Related Officers

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

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

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8