Rise N’ Shine Farm, Inc. Warning Letter Details

Summary

Rise N' Shine Farm, Inc. produced shell eggs that violated the Prevention of Salmonella Enteritidis regulation (21 CFR Part 118) and the Public Health Service Act, with FDA investigators detecting Salmonella Enteritidis in environmental samples collected from the farm during an October 2023 inspection. The facility failed to maintain adequate sanitation controls and did not comply with required preventive measures for shell egg production, storage, and transportation, rendering the eggs adulterated under the Federal Food, Drug, and Cosmetic Act due to preparation under insanitary conditions. The company submitted multiple written responses with corrective actions between November 2023 and January 2024 following the FDA's issuance of Form FDA 483 inspectional observations.