# FDA 483 - FreshRealm, Inc - October 22, 2025

Source: https://www.keypedia.com/records/483/freshrealm-inc/deff0613-7d88-4cca-8053-08a8a86abfc0

> FDA 483 for FreshRealm, Inc on October 22, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FreshRealm, Inc
- Inspection Date: 2025-10-22
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: The FDA inspection of FreshRealm, Inc. in Indianapolis, IN, revealed critical deficiencies in their HACCP plans and overall sanitation practices. The firm failed to identify necessary critical control points for food safety hazards like Clostridium botulinum and did not adequately address recontamination or cross-contact risks. Widespread unsanitary conditions, including condensation dripping onto products and pooling water, were observed throughout the facility, indicating significant risks to product safety and public health.

## Related Documents

- [483 - 2025-05-28](https://www.keypedia.com/records/483/freshrealm-inc/318b193b-d47d-494b-a3fb-6a974d341536)

## Related Officers

- [Misty D Harvey, Investigator](https://www.keypedia.com/people/misty-d-harvey-investigator/6c7c7c76-5c7e-4c5d-b88c-5c7d75a51adb)
- [Brian J Davis, Investigator](https://www.keypedia.com/people/brian-j-davis-investigator/e6dda492-d160-4394-b822-daf899049e91)
- [Jennifer R Johnson, Investigator](https://www.keypedia.com/people/jennifer-r-johnson-investigator/48ac060f-a5db-4d93-ae02-17a765846291)
- [Tessy O Martins, Investigator](https://www.keypedia.com/people/tessy-o-martins-investigator/0c648f8b-0d3c-4ed0-ab70-70f1cd1eb006)
- [Athena L Douglas, Investigator](https://www.keypedia.com/people/athena-l-douglas-investigator/eff5c877-958c-4d8f-b357-e87158c28754)

Company: https://www.keypedia.com/companies/freshrealm-inc/a20fc320-3ce9-4d52-9849-a18cdfedc324

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