FDA 483 - FreshRealm, Inc - May 28, 2025

FreshRealm LLC in Indianapolis, IN, was issued a Form 483 following an inspection from April 7 to May 28, 2025, citing significant deficiencies in their food safety practices. The firm failed to implement process preventive controls, leading to a positive Listeria monocytogenes finding and observed unsanitary employee practices. Additionally, the company's HACCP plan was found inadequate, lacking critical control points for Clostridium botulinum and failing to identify reasonably likely food safety hazards like Listeria monocytogenes, Pathogenic E. coli, and Salmonella.