FDA 483 - FreshRealm, Inc - October 22, 2025

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.