FDA issued a Warning Letter to an Ohio Bakery for the following issues:
Lack of Allergen Preventive Control for Sesame
- The "facility’s written hazard analysis for the buns did not consider allergen cross-contact at all steps where your sesame seed buns and non-sesame seed buns are made on shared equipment (e.g., “(b)(4),” “Baking,” “Depanning,” “Cooling,” and “(b)(4)”). Your facility manufactures at least 21 bun products that contain allergens (such as wheat, soy, and sesame); products containing different allergen profiles (i.e., with or without sesame seeds) are processed on shared equipment and using shared utensils on the same production day."
- The facility did "not adequately controlling the hazard of allergen cross-contact during our inspection. FDA investigators observed apparent sesame residue on the “(b)(4) conveyor” after sanitation had been completed for the changeover from a sesame seed bun batch to a non-sesame seed bun batch produced on shared equipment. Our investigators observed sesame seeds immediately after the buns were depanned, which you consider to be part of the bun cooler. When this was pointed out by the investigators, the non-sesame seed bun was already traveling along the conveyor with sesame seed residue still present even though an employee was trying to clean it."
Lack of Sanitation Preventive Control in Post-Process Environment
- "Did not appropriately evaluate a known or reasonably foreseeable hazard to determine whether it required a preventive control in your RTE bun products, as required by 21 CFR 117.130(a)(1). Your facility’s written hazard analysis considered biological contamination from the environment at certain post-baking steps but did not identify it as requiring a preventive control at processing steps such as “Depanning,” “Cooling,” “(b)(4), and Packaging.” Your RTE buns are exposed to the environment prior to packaging where they could be contaminated with environmental pathogens such as Salmonella and Listeria monocytogenes."
- The "investigators observed several instances where you did not record sanitation activities at the post-baking steps in your process and did not take corrective actions when sanitation was not performed. Our review of your “Master Sanitation Schedule” records from June 3, 2022, through January 6, 2023, found that you did not record sanitation activities at the frequency for which they should occur. When asked by our investigators about the missing sanitation records, your Senior Engineer stated if there was no record then sanitation did not happen."
Lack of Corrective Action to Environmental Samples
- During the investigators’ review of your environmental monitoring records, it was noted that you have had at least four instances in the not ready-to-eat areas in your facility where you had either a suspected positive or confirmed positive for Listeria with no further action taken.
Pest Control
- At least one live mouse was observed between pallets of (b)(4) bags of (b)(4) brand Pure Granulated Sugar in the warehousing area. Eight incidents of rodent activity were documented in the shipping area, tray washing room, boiler room, and break room by your pest control operator between the period of May 18, 2022, to January 18, 2023, including rodent activity on January 4 and January 18, 2023, in the warehousing area where FDA investigators observed a live rodent during the inspection.
- Apparent rodent excreta pellets (AREPs) were observed on pallets and flooring in the warehousing areas"
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/schwebel-baking-company-653005-06092023
FDA Warning LetterSchwebel Baking Company
MARCS-CMS 653005 — JUNE 09, 2023
