Easy Moon, Inc. - Ramona Egg Ranch – FDA Warning Letter, Jan 17, 2014

On July 3, 2014, the FDA issued a Warning Letter to Easy Moon, Inc. / Ramona Egg Ranch following an inspection from January 15-17, 2014. The inspection revealed serious violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs regulation (21 CFR Part 118), rendering their shell eggs adulterated under the FD&C Act and in violation of the PHS Act.

Key violations include: 1. **Inadequate SE Prevention Plan:** The written plan failed to address procurement of SE-monitored pullets and did not include all biosecurity measures, such as the observed foot bath. 2. **Failure to Procure SE-Monitored Pullets:** Pullet environmental testing for SE was conducted outside the required 14-16 weeks of age period. 3. **Deficient Rodent and Fly Control:** The SE plan lacked defined acceptable levels for rodent and fly activity, despite observations of numerous dead and live rodents and unaddressed rodent holes. 4. **Poor Sanitation and Pest Harborage:** Debris and tall vegetation were observed inside and outside poultry houses, providing harborage for pests. A dead chicken carcass and cow manure were also noted. 5. **Failure to Prevent Wild Bird Entry:** At least 20 wild birds were observed entering and exiting the poultry house through roof openings, flying into cages near