Inspections, Compliance, Enforcement, and Criminal Investigations
Bellisio Foods Inc 1/29/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Cincinnati District Office
6751 Steger Dr.
Cincinnati, OH 45237
VIA United Parcel Service
January 29, 2013
Joel Conner, Chairman and Chief Executive Officer
Bellisio Foods, Inc.
1201 Harmon Place
Minneapolis, MN 55403
WARNING LETTER CIN-DO 13-391920-11
Dear Mr. Conner:
We inspected your seafood processing facility, located at 100 E. Broadway St., Jackson, OH, on November 27 – 29, 2012. 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 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 entrees 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 December 17, 2012, has been received. However, your response is not adequate because the deviations observed during the inspection have not been corrected. Moreover, further review has identified additional deviations, which are included below.
Your significant violations are as follows:
1. You must conduct a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.” However, your firm’s HACCP plan for frozen entrees containing shrimp does not list the food safety hazard of allergens, including but not limited to shrimp, milk, and wheat.
In addition, your December 17, 2012, response indicates that prerequisite programs are in place to cover allergens other than shellfish, such as wheat and milk. A prerequisite program cannot be used in lieu of a critical control point to reduce or eliminate a hazard that is reasonably likely to occur.
2. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6 (a) and (c)(2). 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 HACCP plan for frozen entrees containing shrimp does not list the sauce holding tank, the rework/carryover sauce, the pasta blanching, or the pasta filling processing steps as critical controls points to control the food safety hazard of pathogen growth and toxin formation.
3. 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”. However, your HACCP plan for frozen entrees containing shrimp lists a critical limit at the cooking and cooling critical control point that is not adequate to control the food safety hazard of pathogen growth and toxin formation. Specifically, the critical limit for cooking and cooling should include both time and temperature parameters. Your critical limit at the cooking and cooling critical control point only lists a minimum temperature.
Additionally, your HACCP plan for frozen entrees containing shrimp lists a critical limit at the metal detection critical control point that is not adequate to control the food safety hazard of metals. Your critical limit does not ensure that all product goes through the metal detector and that there is no metal in the product.
We suggest that you use the Fish & Fisheries Products Hazards & Controls Guidance: Fourth Edition to evaluate your firm’s operation regarding seafood products. 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.
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm complies with the Act, the seafood HACCP regulations (21 CFR Part 123), the Current Good Manufacturing Practice regulations (21 CFR Part 110), and the Food Labeling regulations (21 CFR Part 101). 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 reinspection. A reinspection 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. Reinspection costs include all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees. FDA will assess and collect fees associated with this reinspection 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 reply should be sent to the U. S. Food and Drug Administration, Attention: Karen Gale Sego, Compliance Officer, 6751 Steger Dr., Cincinnati, OH 45237. Your response should outline the specific steps you have taken to correct these violations. Your response should include your revised HACCP plans and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
If you have questions regarding any issue in this letter, please contact Karen Gale Sego, Compliance Officer, at (513) 679-2700 extension 2164 or firstname.lastname@example.org.
Paul J. Teitell