As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
Schwebel Baking Company
Youngstown, OH
A food firm in Ohio is on notice from the FDA for serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation. These violations include the presence of rodents, flies, and Listeria in their ready-to-eat (RTE) processing facility.
In a June 9, 2023, warning letter, the FDA described a Jan. 30 through Feb. 3, 2023, inspection of Schwebel Baking Company’s ready-to-eat (RTE) bread roll manufacturing facility in Youngstown, OH.
The FDA’s inspection revealed that the firm was not in compliance with regulations and resulted in the issuance of an FDA Form 483. The significant violations are as follows:
Hazard Analysis and Risk-Based Preventive Controls:
1. The firm did not identify and evaluate a known or reasonably foreseeable hazard to determine whether it required a preventive control for their RTE sesame seed and non-sesame seed buns, as required. Specifically, the facility’s written hazard analysis for the buns did not consider allergen cross-contact at all steps where their sesame seed buns and non-sesame seed buns are made on shared equipment (e.g., “(redacted),” “Baking,” “Depanning,” “Cooling,” and “(redacted)”). Their 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. Therefore, allergens are a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in their circumstances would identify allergens as a hazard requiring a preventive control. Food allergen controls include procedures, practices, and processes employed for ensuring protection of food from allergen cross-contact including during storage, handling, and use.
Nevertheless, they have a written procedure, “Allergen Management Program,” which is intended to cover allergen management during the storage of raw materials and finished products, production of finished products, sanitation, and finished product labeling. In this procedure they identify sesame seeds as a major allergen used in their facility. The procedure states that “validated allergens clean out shall be done between the production of allergen containing products and non-allergen containing products,” but it does not address what equipment is to be cleaned. They have cleaning procedures for shared equipment but the only procedure which specifically mentions sesame seeds is their “Depanner Cleaning Procedure,” which does not specify the frequency of the cleaning. According to their “Master Sanitation Schedule,” the depanner is only cleaned (redacted), even though both types of runs can occur during a (redacted). In addition, the bun cooler where the buns are directly on the conveyor belt does not address cleaning between allergens or allergens at all, and the frequency of cleaning is identified as (redacted).
Furthermore, they were not adequately controlling the hazard of allergen cross-contact during our inspection. FDA investigators observed apparent sesame residue on the “(redacted) 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. FDA investigators observed sesame seeds immediately after the buns were depanned, which they 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. The Plant Manager stated their firm was only cleaning the “(redacted) conveyor” and “(redacted) conveyor” sections of the cooler as they were determined to be the highest risk area in terms of cross-contact. The “(redacted) conveyor” and “(redacted) conveyor” is a considerable distance away from where sesame seeds were observed. The rest of the cooler belt/chain is not currently being cleaned between unlike allergens. The plant manager stated the firm has approved a purchase of (redacted) for this belt/chain, but the purchase is not slated to be completed until late (redacted). FDA previously informed them of their concerns related to allergen cross-contact during FDA’s 2022 inspection of their facility and subsequent Regulatory Meeting held on Sept. 12, 2022.
2. The firm did not appropriately evaluate a known or reasonably foreseeable hazard to determine whether it required a preventive control in their RTE bun products, as required. Their 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,” “(redacted), and Packaging.” Their 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 packaged buns do not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize pathogens. Therefore, contamination with environmental pathogens is a known or reasonably foreseeable hazard. Further, a knowledgeable person manufacturing/processing food in their circumstances would identify contamination with environmental pathogens as requiring a preventive control. Preventive controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens.
Nevertheless, they have written sanitation procedures (“SSOPs”), and they document their sanitation activities on their “Master Sanitation Schedule,” which lists cleaning tasks and dates completed. The frequency of cleaning is (redacted) or longer, which is not frequent enough to significantly minimize or prevent the hazard of recontamination with environmental pathogens.
Furthermore, preventive controls are subject to preventive control management components (monitoring, verification, and corrective actions) as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility’s food safety system. However, FDA investigators observed several instances where they did not record sanitation activities at the post-baking steps in their process and did not take corrective actions when sanitation was not performed. FDA review of their “Master Sanitation Schedule” records from June 3, 2022, through Jan. 6, 2023, found that they did not record sanitation activities at the frequency for which they should occur. When asked by FDA investigators about the missing sanitation records, their Senior Engineer stated if there was no record then sanitation did not happen. For example, according to their “Master Sanitation Schedule”:
- The depanner cups will be washed and changed (redacted). Their records show this was only completed for the (redacted).
- The depanner will be blown down (redacted). Their record shows this was only completed for (redacted) of the (redacted) reviewed: (redacted).
- The cooler will be washed every (redacted). Their records show this was only completed on the (redacted) ending in (redacted).
- The metal detector will be washed (redacted). Their records show this was only completed (redacted) reviewed: (redacted).
- The (redacted) will be blown down (redacted). Their records show this was only completed (redacted) reviewed: (redacted).
- The (redacted) parts will be removed and washed (redacted). Their records show this was only completed (redacted) reviewed: (redacted).
Current Good Manufacturing Practice:
1. The firm did not conduct all food manufacturing, processing, packing, and holding under such conditions and controls as necessary to minimize the potential contamination of food as required. Specifically, during the investigators’ review of their environmental monitoring records, it was noted that they have had at least four instances in the not ready-to-eat areas in their facility where they had either a suspected positive or confirmed positive for Listeria with no further action taken. Specifically,
- The firm’s test reports dated Nov. 17, 2022, and Nov. 23, 2022, and Dec. 14, 2022, identified Listeria suspect for the (redacted) and (redacted), respectively. The (redacted) are pre-bake, and the product is not considered RTE at this point.
- Their test report dated Dec. 16, 2022, identified a confirmed Listeria positive of the (redacted).
- Their test report dated January 23, 2023, identified confirmed Listeria positives of the (redacted) and (redacted).
- The firm was not able to provide information during the inspection that these positive results were addressed such as by recleaning or retesting.
2. The firm did not exclude pests from their food plant to protect against contamination of food as required. Specifically, during the inspection, FDA investigators observed the following:
- At least one live mouse was observed between pallets of (redacted) bags of (redacted) 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 their pest control operator between the period of May 18, 2022, to Jan. 18, 2023, including rodent activity on Jan. 4 and Jan. 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, including:
1. Approximately 15 AREPs next to rolls of (redacted) used for identifying private-label buns. The (redacted) are in direct contact with finished product after packaging.
2. Three AREPs approximately 1” from boxes of an ingredient used to manufacture buns.
3. Three AREPs on the floor directly beneath and two AREPs on the floor near the rodent trap located approximately 6’ away from the same boxes of the ingredient used to manufacture buns.
4. AREPs too numerous to count on an empty stack of pallets located near the partial wall which separates ingredients from finished product storage.
- Apparent fruit flies too numerous to count were observed in the ingredient pit where bulk ingredient containers were stored. Many were observed on food-contact surfaces of the containers verbally identified as being clean. Fruit fly activity was also noted in this area by their pest control operator as documented on the Pest Activity Report they provided.
- Three live apparent flour beetles were observed on (redacted) bags of (redacted) brand Pure Granulated Sugar where ingredients were staged by the mixer.
Additionally, the pallets in their warehousing area were generally positioned only a few inches apart from one another making sanitation and pest monitoring difficult. Similar issues with stored product and spacing were noted by their pest control operator on Nov. 29, 2022, and Dec. 7, 2022.
The full warning letter can be viewed here.
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