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  5. Schwebel Baking Company - 653005 - 06/09/2023
  1. Warning Letters

WARNING LETTER

Schwebel Baking Company MARCS-CMS 653005 —

Delivery Method:
VIA UNITED PARCEL SERVICE AND VIA E-MAIL
Product:
Food & Beverages
Recipient:
Recipient Name
Steve Cooper
Recipient Title
President/CEO
Schwebel Baking Company

965 E Midlothian Blvd
Youngstown, OH 44502
United States

coopers@schwebels.com
Issuing Office:
Division of Human and Animal Food Operations East V

United States

June 9, 2023

WARNING LETTER
Reference #653005

Dear Mr. Cooper:

The U.S. Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) bread roll manufacturing facility at 121 O’Neill Dr, Hebron, OH 43025, from January 30 through February 3, 2023. During our inspection, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, part 117 (21 CFR part 117).

Based on FDA’s inspectional findings, we have determined the RTE bread rolls (buns) processed in your facility are adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)].

At the conclusion of the inspection, the FDA investigators issued an FDA Form 483 (FDA-483), Inspectional Observations. You provided a response to the inspection on February 22, 2023, describing corrective actions taken or planned by your firm. After reviewing the inspectional findings and the response that your firm provided, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility. We address your responses below.

Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):

1. You did not identify and evaluate a known or reasonably foreseeable hazard to determine whether it required a preventive control for your RTE sesame seed and non-sesame seed buns, as required by 21 CFR 117.130(a)(1). Specifically, your 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. Therefore, allergens are a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in your 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 (see 21 CFR 117.135(c)(2)(i)).

Nevertheless, you 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 you identify sesame seeds as a major allergen used in your 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. You have cleaning procedures for shared equipment but the only procedure which specifically mentions sesame seeds is your “Depanner Cleaning Procedure,” which does not specify the frequency of the cleaning. According to your “Master Sanitation Schedule,” the depanner is only cleaned (b)(4), even though both types of runs can occur during a (b)(4). 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 (b)(4).

Furthermore, you were 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. Your Plant Manager stated your firm was only cleaning the “(b)(4) conveyor” and “(b)(4) conveyor” sections of the cooler as they were determined to be the highest risk area in terms of cross-contact. The “(b)(4) conveyor” and “(b)(4) 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. Your plant manager stated the firm has approved a purchase of (b)(4) for this belt/chain, but the purchase is not slated to be completed until late (b)(4). We previously informed you of our concerns related to allergen cross-contact during our 2022 inspection of your facility and subsequent Regulatory Meeting held on September 12, 2022.

In your response dated February 22, 2023, you provided photographs of cleaned equipment and an updated “Hazard Register” (which is separate from your hazard analysis) with “the control of cross contamination of sesame seed potential,” but did not conclude the hazard required a preventive control. You identified the control measures as your Allergen Program, a Post Cleaning Allergen Sanitation Inspection, and revised SSOPs for the sanitation control of Allergen Cross Contamination to assure a thorough sanitation and ATP testing at allergen changeover frequency for the Depanner Cleaning, Bun Cooler, Bun Baggers and Metal Detector. You also provided a completed Post Cleaning Allergen Inspection document dated February 13, 2023. The allergen procedures you have implemented may be part of your allergen preventive control. The implementation of your preventive controls to significantly minimize and prevent the hazard of allergen cross-contact will be verified during the next FDA inspection.

2. You 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 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 your 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 (see 21 CFR 117.135(c)(3)).

Nevertheless, you have written sanitation procedures (“SSOPs”), and you document your sanitation activities on your “Master Sanitation Schedule,” which lists cleaning tasks and dates completed. The frequency of cleaning is (b)(4) or longer, which is not frequent enough to significantly minimize or prevent the hazard of recontamination with environmental pathogens (see 21 CFR 117.135(a)(1)).

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 (see 21 CFR 117.140). However, our 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. For example, according to your “Master Sanitation Schedule”:

  • The depanner cups will be washed and changed (b)(4). Your records show this was only completed for the (b)(4).
  • The depanner will be blown down (b)(4). Your record shows this was only completed for (b)(4) of the (b)(4) reviewed: (b)(4).
  • The cooler will be washed every (b)(4). Your records show this was only completed on the (b)(4) ending in (b)(4).
  • The metal detector will be washed (b)(4). Your records show this was only completed (b)(4) reviewed: (b)(4).
  • The (b)(4) will be blown down (b)(4). Your records show this was only completed (b)(4) reviewed: (b)(4).
  • The (b)(4) parts will be removed and washed (b)(4). Your records show this was only completed (b)(4) reviewed: (b)(4).

Current Good Manufacturing Practice (21 CFR Part 117, Subpart B):

1. You 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 by 21 CFR 117.80(c)(2). Specifically, 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. Specifically,

  • Your test reports dated November 17, 2022, and November 23, 2022, and December 14, 2022, identified Listeria suspect for the (b)(4) and (b)(4), respectively. The (b)(4) are pre-bake, and the product is not considered RTE at this point.
  • Your test report dated December 16, 2022, identified a confirmed Listeria positive of the (b)(4).
  • Your test report dated January 23, 2023, identified confirmed Listeria positives of the (b)(4) and (b)(4).
  • You were not able to provide information during the inspection that these positive results were addressed such as by recleaning or retesting.

In your response you stated that you revised your Environmental Monitoring Program on February 15, 2023 “to implement the appropriate procedure for [L]isteria and [S]almonella swabbing zone sample sites and assurance of compliance of positive result corrective actions practices, with assurance of sanitation and re-testing to be completed and analyzed until a negative result is obtained three consecutive times.” However, you did not provide any corrective actions in response to the previous positive Listeria findings described in this letter. You should address your repeated Listeria positives in the (b)(4) and (b)(4) to determine if your sanitation program is working effectively.

2. You did not exclude pests from your food plant to protect against contamination of food as required by 21 CFR 117.35(c). Specifically, during the inspection, FDA investigators observed the following:

  • 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, including:

1. Approximately 15 AREPs next to rolls of (b)(4) used for identifying private-label buns. The (b)(4) 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 your pest control operator as documented on the Pest Activity Report you provided.
  • Three live apparent flour beetles were observed on (b)(4) bags of (b)(4) brand Pure Granulated Sugar where ingredients were staged by the mixer.

Additionally, the pallets in your 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 your pest control operator on November 29, 2022, and December 7, 2022.

We previously informed you of our concerns related to pest exclusion during the 2022 inspection of your facility and the Regulatory Meeting held on September 12, 2022.

Your response stated that you have increased pest control services to (b)(4) with temporary interior mouse traps and (b)(4) traps added, along with drain treatment. You further stated that you have increased the frequency of drain cleaning and pallet racking system in your “Master Sanitation Schedule.” We will verify the effectiveness of your corrective actions during the next FDA inspection.

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our findings and provides you an opportunity to address them. You should take prompt action to correct any violations. Failure to adequately address this matter may lead to legal or regulatory action, including, without limitation, seizure, and injunction.

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen (15) working days, state the reason for the delay and the time frame within which you will complete the correction. If you believe you have complied with the FD&C Act and FDA regulations, include your reasoning and any supporting information for our consideration.

Please send your firm’s response to Shondra N. Gipson, Compliance Officer, at ORAHAFEAST5FirmResponses@fda.hhs.gov. Alternatively, you may mail your response to Shondra N. Gipson, 404 BNA Drive, Suite 500, Nashville, TN 37217. If you have any questions about this letter, please contact Shondra N. Gipson at 615-366-7867.

Sincerely,
/S/

Steven B. Barber
Director, Division V
Office of Human and Animal Foods Operations-East

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