haciendas morales – FDA Warning Letter, May 2, 2013

On April 24-May 2, 2013, the FDA inspected Hacienda Morales dba Granja Avícola Morales' shell egg facility in Moca, Puerto Rico, and found serious violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs regulation (21 CFR Part 118). These violations render their shell eggs adulterated under the FD&C Act and in violation of the PHS Act.

Key violations include: * **SE Prevention Plan Deficiencies:** The plan failed to require SE monitoring for procured pullets, and the firm lacked documentation of such monitoring. * **Failure to Implement SE Prevention Plan:** The firm did not monitor for rodents using appropriate methods or maintain records of rodent control. Biosecurity measures, such as sanitizing boots, utensils, tools, and vehicles, were not implemented or documented. * **Pest Control Issues:** Wild birds were observed inside the layer house, and physical barriers were absent. Fly monitoring, including the use of mechanical traps, was not implemented or documented. * **Recordkeeping Failures:** The firm failed to maintain records documenting compliance with refrigeration requirements (eggs held/transported at or below 45°F) and environmental sampling procedures. The SE Prevention Plan also lacked specific details on refrigeration practices.

The firm's May 13, 2013, response acknowledged some issues and outlined corrective actions, such as using