FDA issued a warning letter on June 9, 2023, after inspecting Schwebel Baking Company's Hebron, Ohio ready-to-eat bread roll facility and finding Listeria monocytogenes, live mice, rodent fecal matter within inches of food ingredients, and fly infestations — violations of 21 CFR Part 117 CGMP and preventive controls requirements.

Schwebel Baking Company — Listeria, Mice, Pest Infestation / FDA Warning Letter (2023)

Outcome: FDA issued a warning letter on June 9, 2023, documenting Listeria monocytogenes contamination, a live mouse, rodent fecal matter within one inch of food ingredients, and fly infestations at Schwebel Baking Company's ready-to-eat bread roll facility in Hebron, Ohio — no recall was ordered but the firm was required to take immediate corrective actions.

Schwebel Baking Company, a regional bakery headquartered in Youngstown, Ohio, operates a ready-to-eat bread roll manufacturing facility at 121 O'Neill Dr, Hebron, Ohio. FDA investigators inspected the Hebron facility from January 30 through February 3, 2023. The inspection found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117), and the facility's RTE products were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Specific findings documented in the June 9, 2023 warning letter included: (1) environmental testing conducted by the company on December 16, 2022, and January 23, 2023, both yielded positive Listeria monocytogenes results in the facility; (2) apparent rodent excreta pellets (AREPs) — rodent feces — were found in multiple locations within feet of food materials, with one instance documenting fecal matter within one inch of a pallet containing granulated sugar used in the bread rolls; (3) FDA investigators directly observed at least one live mouse between pallets of sugar; and (4) fly activity was documented inside the facility including in areas proximal to food production.

The facility's preventive controls program had failed to identify and correct the pest activity and Listeria-positive environmental findings as they emerged. The FDA warning letter required the firm to submit a written response within 15 working days detailing corrective actions. No product recall was announced in connection with this warning letter, though the Hebron facility's bread rolls had been produced under conditions that created contamination risk.

Primary Source: Schwebel Baking Company - 653005 - 06/09/2023 | FDA