FDA WARNING_LETTER - Schwebel Baking Company - February 03, 2023

The FDA inspected a ready-to-eat (RTE) bread roll manufacturing facility from January 30 to February 3, 2023, finding serious violations of the CGMP & PC rule (21 CFR part 117). The RTE bread rolls were deemed adulterated due to insanitary conditions.

Key violations include: 1. **Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):** * Failure to identify and evaluate allergen cross-contact (sesame) as a hazard requiring a preventive control on shared equipment, despite a written "Allergen Management Program." Observed sesame residue on equipment after sanitation for changeover. * Failure to identify environmental pathogens (Salmonella, Listeria monocytogenes) as a hazard requiring a preventive control at post-baking steps (Depanning, Cooling, Packaging). Sanitation frequency was insufficient, and records showed missing sanitation activities.

2. **Current Good Manufacturing Practice (21 CFR Part 117, Subpart B):** * Failure to minimize potential contamination: Environmental monitoring records showed multiple suspected or confirmed Listeria positives in non-RTE areas with no further action. * Failure to exclude pests: Approximately 15 apparent rodent excreta pellets (AREPs) were observed near finished product packaging, ingredients, and on pallets. Pest control operator also noted similar issues.