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Schwebel Baking Company's ready-to-eat bread roll manufacturing facility in Hebron, Ohio was found to have produced adulterated products prepared under insanitary conditions that could become contaminated with filth or pose health risks. FDA investigators conducting an inspection from January 30 through February 3, 2023, identified serious violations of Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls regulations under 21 CFR Part 117, specifically including failure to identify and evaluate known or reasonably foreseeable hazards for sesame seed and non-sesame seed buns. The facility's written hazard analysis was inadequate, failing to meet the requirement under 21 CFR 117.130(a)(1) to properly assess preventive controls needed for their products.