Public Health Service Food and Drug Administration
Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761
VIA United Parcel Service
June 12, 2014
Joel Conner, Chairman and Chief Executive Officer
Bellisio Foods, Inc.
525 Lake Avenue South
Duluth, MN 55802-2300
WARNING LETTER CIN-14-421088-14
Dear Mr. Conner:
The U.S. Food and Drug Administration inspected your frozen entrée processing facility, located at 100 E. Broadway St., Jackson, OH, on November 19 – December 18, 2013. We found that you have serious violations of the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). Based on our findings, your frozen entrées are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] in that they were prepared, packed, or held under insanitary condition whereby they may have been contaminated with filth or rendered injurious to health.
In addition, we found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 110 & 123). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)]. Accordingly, your frozen entrées containing shrimp are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulations, and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your response dated January 9, 2014, has been received. However, your response does not address all of our concerns. The observations indicated as corrected in the letter, such as, employee training and equipment repairs, will be evaluated for adequacy during our next inspection. Overall, our biggest issue is that you consider all FDA regulated products produced at your firm to be not ready to eat. We reviewed the revised HACCP plans submitted with your response. Based on our review, significant seafood HACCP deviations still exist. The significant deviations are noted below:
1. You must monitor sanitation conditions and practices with sufficient frequency to ensure compliance with good manufacturing practice requirements in 21 CFR Part 110 to comply with 21 CFR 123.11 (b). However, your firm did not monitor the protection of food from adulteration with sufficient frequency to ensure compliance with the current Good Manufacturing Practices requirements in 21 CFR 110. Specifically,
Our inspection found that your entrée processing equipment, (b)(4) Neither the equipment nor the processing area in which the equipment is contained is maintained at temperatures that would prevent pathogen the growth of microorganisms and toxin formation. In addition, our inspection found the temperature (b)(4)
Moreover, your finished product testing for 2013 revealed Escherichia coli (E. coli) in one lot of shrimp with pasta and vegetables, in addition to, one lot of wheels and cheese, one lot of lasagna mozzarella, and one lot of stir-fry rice with vegetables. The amount of E. coli ranged from 40 to 550 CFU/g in these four products. E. coli is an indicator of filth and insanitary conditions.
Your January 9, 2014, response includes a letter from your processing authority stating that your firm has control of its processes during production because the microbiological levels are typical for a partially cooked non-ready to eat product and if the labeled cooking directions are followed, there is a very low likelihood of microbial hazards. First, FDA considers your products ready to eat, in that they appear to be fully cooked because the ingredients that comprise the finished meal are fully cooked. In addition, FDA considers the presence of an indicator of fecal contamination in either raw or ready-to-eat food objectionable.
Although, your firm typically (b)(4), additional review of finished product testing records found at least five occasions in 2013, where a meat and/or poultry product was ran (b)(4) followed by either a seafood or non-seafood FDA regulated product (b)(4).
2. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met to comply with 21 CFR 123.6 (c) (3). A critical limit is defined in 21 CFR 123.3 (c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." A critical control point is defined in 21 CFR 123.3(b) as a “point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels”. However, your firm’s revised HACCP plan, Sauce Preparation – Rework Temperature [Refrigerated & Frozen Storage] provided with your January 9th response does not list a critical control pointlists an inadequate critical limit. for refrigerated storage of rework sauce. While your revised HACCP plan identifies this critical control point as “Refrigerate & Frozen Storage”, the corresponding critical limits listed for that critical control point appear to be associated with product cooling or product holding, rather than storage. FDA recommends that firms ensure that products are ambient storage temperatures be maintained at or below 40°F, and that storage conditions are monitored with equipment capable of continuously monitoring and recording refrigerated storagethose conditions.
Further, your firm’s revised HACCP plan Sauce Preparation – Rework Temperature [Refrigerated & Frozen Storage] provided with your January 9th response lists critical limits that are not adequate to control pathogen growth and toxin formation. As a critical control point for cooling we recommend that your firm ensure the products are cooled to 70° F within 2 hours and further cooled to 40° F in an additional 4 hours. As a critical control point for holding, we recommend a temperature of 40° F when a firm does not intend to include a hold time limit.
3. You must have a HACCP plan that at a minimum lists monitoring procedures and their frequency for each critical control point to comply with 21 CFR 123.6(c)(4). However, your firm’s revised HACCP plan, D. Sauce Preparation – CCP1 Kettle Temperature [Cook & Cooling After Cook], provided with your January 9th response does not list monitoring procedures adequate to control pathogen growth and toxin formation. Your plan lists “Chart recorders will monitor from start to end the time and temperature continuously during the batch/blend operation”, however this appears to be associated with the cooling portion of this combined critical control point and not the cooking portion. The Cook part of the CCP that lists the critical limits as (b)(4) does not include any monitoring procedures. Moreover, the HACCP plan does not identify whether the temperature critical limit (b)(4) represents internal product temperature, or temperature of the cooking apparatus, etc.
Your firm’s revised HACCP plan Sauce Preparation – Rework Temperature [Refrigerated & Frozen Storage] provided with your January 9th response does not list adequate monitoring procedures at “CCP(1): Finished Product Labeling “ adequate to control the food safety hazard of undeclared allergens, specifically sulfites (i.e., sulfating agents) in the shrimp. For example, your plan does not list controls to monitor for the presence of sulfites in the shrimp or whether you intend to use incoming shrimp that are sulfite-free and how you would intend to monitor that all raw material shrimp are free of sulfites; or whether you intend to conduct label reviews to ensure that all lots of labels include the sulfites as an ingredient in the shrimp for shrimp that have been treated with sulfites.
We suggest that you use the Fish & Fisheries Products Hazards & Controls Guidance: Fourth Edition to evaluate your firm’s operation and to establish the necessary critical control points to control those hazards that are reasonably likely to occur in the absence of controls at those points. While the guidance is not a binding set of requirements it does provide information that will most likely result in a HACCP plan that is acceptable to FDA. Firms may choose other control measures, but they are then responsible for scientifically establishing their adequacy. Your firm should be aware that the regulatory requirements and safety recommendations of FDA may differ significantly from the requirements of other agencies. When processing seafood products, you must meet FDA’s requirements.
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm complies with the Act, the Current Good Manufacturing Practice regulations (21 CFR Part 110) and the seafood HACCP regulations (21 CFR Part 123). You should take prompt action to correct these violations. Failure to correct these violations in a prompt manner may result in regulatory actions without further notice, such as seizure, injunction, and/or prosecution.
Additionally, the inspection referenced above identified violations materially related to the food safety requirements of the Act. Accordingly, Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs associated with re-inspection. A re-inspection is one or more inspections conducted following an inspection that identified noncompliance materially related to the food safety requirements of the Act, specifically to determine whether compliance has been achieved. Re-inspection costs include all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees. FDA will assess and collect fees associated with this re-inspection in accordance with Section 743 of the Act.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should be sent to the U. S. Food and Drug Administration, Attention: Stephen J. Rabe, Compliance Officer, 6751 Steger Dr., Cincinnati, OH 45237. If you have questions regarding this letter, you may contact Mr. Rabe at (513) 679-2700 extension 2163 or via e-mail: firstname.lastname@example.org.