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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Noon Hour Food Products, Inc. 9/12/13


Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telelphone: 312-353-5863 


September 12, 2013
Mr. William L. Buhl
Noon Hour Food Products, Inc.
215 North Des Plaines Street
Chicago, Illinois 60661
Dear Mr. Buhl:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your firm, Noon Hour Food Products, Inc., located at 215 N. Des Plaines St., Chicago, IL 60661 from April 9, 2013 to April 18, 2013.  The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). 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 (FD&C Act), [21 U.S.C. § 342(a)(4)]. Accordingly, your herring products 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 regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations were as follows: 
  • 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 Part 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 plans for Marinated Herring in Sour Cream Sauce and Marinated Herring in Wine Sauce do not list the critical control points of first brining (b)(4) and second brining (b)(4) for controlling the food safety hazards of histamine formation and pathogen growth and toxin formation. Based on your process,FDA recommends that you monitor the brine temperature at the start of each brining process with a temperature-indicated device (e.g., a thermometer) and then monitor the ambient air temperature in the cooler using a continuous temperature-recording device (e.g., a recording thermometer), to ensure that the temperatures are at or below 40°F at all times during these refrigerated processing steps, along with monitoring any additional critical factors that need to be controlled during these brining processes, such as brine to fish ratio.


  • You must have a HACCP plan that, at 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 firm’s HACCP plans for Marinated Herring in Sour Cream and Marinated Herring in Wine Sauce do not list a critical limit at your “filling” critical control point to control histamine and pathogen growth and toxin formation. Specifically, your plans list “not present” under the critical limit column. Your plans, however, show that you are monitoring the pH of your cream and wine mixing sauces at the two previous critical control points (i.e., prior to filling) with the mixing sauces at a pH value of (b)(4). However, in addition to monitoring the acid strength of your mixing sauce, FDA recommends that you monitor all critical factors to ensure that your finished products (i.e., the fish) achieve a pH of 5.0 or below for these refrigerated products. Other critical factors should include the pH of finished product. We recommend that these critical limits be listed at the “filling” critical control point since this addresses your finished/end products.


  • Predetermined corrective action plans included in a firm’s HACCP plan, to be taken whenever there is a deviation from a critical limit, must be appropriate to comply with 21 CFR 123.7(b).   However, your corrective action plans for Marinated Herring in Sour Cream Sauce and Marinated Herring in Wine Sauce at the Storage critical control point are not appropriate to control histamines. Specifically, your corrective action plans do not include how many fish will be analyzed or what the limit for histamines is.   In addition, pathogen growth and toxin formation is a hazard that is reasonably likely to occur at the Storage critical control point. FDA recommends that you also chill and hold the affected product until an evaluation of the total time and temperature exposure is performed. A product with cumulative exposures that exceed the critical limits should be cooked or diverted to a use in which the critical limit is not applicable (taking into consideration the potential for additional hazards such as Staphylococcus aureus toxin that may have been introduced and which is not inactivated by heat), or destroyed, or diverted to a non-food use. Finally, your corrective action plans at the Storage critical control point do not indicate what actions you will take to regain control over the operation after a critical limit deviation. FDA recommends that you also add ice to the product, or move the product in the malfunctioning cooler to another cooler, and make repairs or adjustments to the malfunctioning cooler.


  • You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including maintenance of hand washing, hand sanitizing, and toilet facilities and protection of food, food packaging material, and food contact surfaces from adulteration as evidenced by;
o   Maintenance of hand washing, hand sanitizing, and toilet facilities: 

o   There was no soap and no towels at the hand washing sink in the processing room.

o   Protection of food, food packaging material, and food contact surfaces from adulteration:

o   There were missing ceiling tiles, holes in the ceiling tiles, and corrosion on the ceiling tile supports in the drop ceiling located above the processing/packaging table as well as above the area where Herring is brined in the processing room.

o   There were strip curtains in the cooler that contained a black substance. The drained partially covered Herring is pushed through the strip curtains when removed from the cooler.

o   The ceiling in the Herring processing room was leaking water, approximately two feet away from the processing/packaging table.

  • You must implement an affirmative step which ensures that the fish and fishery products you import are processed in accordance with the Seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2)(ii). However, your firm provided documentation indicating that you may have been intending to comply with affirmative step in 21 CFR 123.12 (a)(2)(ii)(E), of obtaining a written certificate of compliance from the manufacturer and periodically testing the imported fish. The documentation is attests that the (b)(4) operating under a system that is equivalent to the U.S. requirements, and includes an analytical report, also from the manufacturer in (b)(4), which is Herring manufactured by (b)(4).   However, implementation of this part 123.12 (a)(2)(ii)(E) was found inadequate because periodic testing (analysis) must be conducted by your firm, or a competent third party, in order to provide the same level of assurance provided under 21 CFR 123.12(a)(2)(ii)(E) and should address all of the hazards that were reasonably likely to occur in the product before, during and after production, including parasites and pathogen growth and toxin formation.
Additionally, Section 743 of the FD&C Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the FD&C Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means 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 [21 U.S.C. § 379j-31(a)(2)(B)]. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the FD&C Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, or 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.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Rosemary Sexton, Compliance Officer, 550 W. Jackson Blvd., 15th floor, Chicago, IL 60661. Refer to the Unique Identification Number (CMS case # 397558) when replying. If you have questions about the content of this letter, you may contact Ms. Sexton at 312-596-4225 or by email at rosemary.sexton@fda.hhs.gov.
Scott J. MacIntire
District Director