FDA cited a number of issues where the company was not meeting the requirements.
- "Did not have and implement a written 'compliant' Salmonella Enteritidis (SE) Prevention Plan that includes, at minimum, the SE prevention measures required by 21 CFR118.4. Had a plan, but was not viewed as compliant."
- "Did not have written measures to ensure that there is no introduction or transfer of SE into or among poultry houses, as required by 21 CFR 118.4(b). Inspectors observed gaps for potential entry of pests and other animals to the poultry houses (including large gaps in the (b)(4) house), perimeter exhaust fans missing their protective cages, and other fans with protective cages that were not securely fastened."
- "Did not adequately monitor pest activity - the bait consumption was not routinely monitored. Inspectors observed evidence of rodent activity, including droppings and chewed insulation in the (b)(4) house and did not routinely monitor fly activity, did not identify a threshold for acceptable and unacceptable fly activity, and did not identify corrective actions to take if unacceptable activity was observed. Further, flies were observed in the (b)(4) house."
- "SE Prevention Plan did not include cleaning and disinfection procedures for poultry houses, in the event that you have an environment test or egg test that was positive for SE at any point during the life of a flock, as required by 21 CFR 118.4(d)."
- "Did not hold or transport eggs at or below 45°F ambient temperature beginning36 hours after the time of lay, as required by 21 CFR 118.4(e). Your SE Prevention Plan stated “eggs should be stored in a cooler that is (b)(4)”; however, your cooler temperatures routinely exceeded 45°F. For example, from May 4, 2023, through June 4, 2023, the documented cooler temperatures ranged from 51°F to 68°Fconsecutively for 31 days."
- "Did not conduct environmental testing for SE in your poultry houses when laying hens were 40 to 45 weeks of age, as required by 21 CFR 118.5(a). Specifically, the (b)(4) house and the (b)(4) house were tested when the flocks were approximately 48 weeks of age."
- "Did not maintain records regarding your SE Prevention Plan in accordance with the requirements set forth by 21 CFR 118.10."
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/iowa-egg-company-inc-663904-12152023
Iowa Egg Company Inc.
MARCS-CMS 663904 — DECEMBER 15, 2023