# FDA WARNING_LETTER - Schwebel Baking Company - February 03, 2023

Source: https://www.keypedia.com/records/warning_letter/schwebel-baking-company/dea5aaf8-c8c6-44a9-8f01-d97b0c4095d3

> FDA WARNING_LETTER for Schwebel Baking Company on February 03, 2023. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Schwebel Baking Company
- Inspection Date: 2023-02-03
- Product Type: Food
- Office Name: Division of Human and Animal Food Operations - East V
- Summary: 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.

## Related Officers

- [District Director at FDA](https://www.keypedia.com/people/steven-barber/e766c0f7-0002-400f-b83a-a0a6efbf259c)

Company: https://www.keypedia.com/companies/schwebel-baking-company/0458afeb-b353-4d54-960e-e12995eb6058

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-v/8e2b97e8-863d-4c78-bff0-ba5257ac1e51