Zoet Poultry, Inc. – FDA Warning Letter, Aug 23, 2023

On February 9, 2024, the FDA issued a Warning Letter to Zoet Poultry following an inspection from August 15-23, 2023, which revealed serious violations of 21 CFR Part 118 (Shell Egg Production, Storage, and Transportation). These violations render their shell eggs adulterated under section 402(a)(4) of the FD&C Act and in violation of section 361(a) of the PHS Act.

Key violations include: 1. **Lack of a comprehensive SE Prevention Plan (21 CFR 118.4):** * No written procedures for SE-monitored pullet procurement or environmental testing at 14-16 weeks. Their proposed response to a positive pullet test (not accepting flock until negative) is inadequate; egg testing or diversion is required. * Failure to implement rodent monitoring procedures (21 CFR 118.4(c)(1)). Only bait stations were used, no interior monitoring devices observed, records lacked house specificity, and no thresholds for action were identified. Their updated plan still lacks an intervention plan, corrective action thresholds, and complete monitoring records. * Failure to implement fly monitoring procedures (21 CFR 118.4(c)(2)). No spot cards or other methods observed, records lacked house specificity, and no thresholds for action