# FDA 483 - Imbed Biosciences, Inc. - February 14, 2025

Source: https://www.keypedia.com/records/483/imbed-biosciences-inc/a07111d4-a8a6-4d6b-b58d-2cb471f67667

> FDA 483 for Imbed Biosciences, Inc. on February 14, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Imbed Biosciences, Inc.
- Inspection Date: 2025-02-14
- Product Type: other
- Office Name: Minneapolis District Office
- Summary: Imbed Biosciences Inc. in Middleton, WI, was inspected by the FDA from February 10-14, 2025. The inspection revealed significant issues with the firm's corrective and preventive action (CAPA) procedures. Specifically, the firm failed to follow its own written procedures regarding timely closure of CAPAs and verification of corrective actions, indicating a moderate level of non-compliance with quality system requirements.

## Related Officers

- [Shawn Choi](https://www.keypedia.com/people/shawn-choi/77845db3-46a3-4d0f-b94c-428bc251c0dc)

Company: https://www.keypedia.com/companies/imbed-biosciences-inc/98be2791-4a3c-4926-a99f-766c4e80d766

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d