# FDA 483 - Biomat USA, Inc. - December 13, 2024

Source: https://www.keypedia.com/records/483/biomat-usa-inc/5ba4693b-81de-4e20-bde3-656975107200

> FDA 483 for Biomat USA, Inc. on December 13, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biomat USA, Inc.
- Inspection Date: 2024-12-13
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Biomat USA, Inc.'s Source Plasma Center in Terre Haute, IN, revealed that written standard operating procedures for blood and blood component collection were not consistently followed. Observations included failures in donor identification prior to venipuncture and improper verification of applicant donor addresses. These findings indicate procedural deficiencies in critical donor screening and collection processes.

## Related Documents

- [483 - 2024-12-13](https://www.keypedia.com/records/483/biomat-usa-inc/feca85d0-3ac5-4ad6-a729-742b9af3ae3f)

## Related Officers

- [Lesley Mae P. Lutao](https://www.keypedia.com/people/lesley-mae-p-lutao/bfdcc755-28e5-4caf-91f9-b9579df4731e)
- [David A. Moore](https://www.keypedia.com/people/david-a-moore/361e4fe8-caf0-4320-963a-3838616850e2)

Company: https://www.keypedia.com/companies/biomat-usa-inc/3f431465-eedc-461b-adf4-3aa8816d34f0

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0