Inspections, Compliance, Enforcement, and Criminal Investigations

Quality Fisheries dba The Niota Fish Market 4/10/17

 

  

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Chicago District Office
550 W. Jackson Blvd., 15111 Floor
Chicago, IL 60661
Telephone: (312) 353-5863
Fax: (312) 596-4187 

 

April 10, 2017
 
WARNING LETTER
CHI-4-17
 
 
UPS NEXT DAY
SIGNATURE REQUIRED
 
Kirby Marsden, Owner
Quality Fisheries dba The Niota Fish Market
157 Arbor Street, #28
Niota, IL 62358
 
Dear Mr. Marsden,
 
The U.S. Food and Drug Administration (FDA) inspected your seafood processing facility, located at 157 Arbor Street, Niota, IL 62358 on January 17, 2017 through January 26, 2017. During that inspection, we found that you had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123. At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations, listing the deviations found at your firm. However, you have not provided a response with corrections to those deviations. In accordance with 21 CFR 123.6 (g), failure of a processor of fish or fishery products to 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 buffalo fish 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 and the seafood HACCP regulation through links in FDA's home page at www.fda.gov.
 
Your significant deviations are as follows:
  1. Your HACCP plan does not list the food safety hazards that are reasonably likely to occur to comply with 21 CFR 123.6 (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 HACCP plan for buffalo fish, does not list the food safety hazards of environmental and chemical contaminants & pesticides, allergens, and metal inclusion.
    1. You are a primary processor of buffalo fish, caught from both the (b)(4) and (b)(4), as such you need to control for the food safety hazards of environmental and chemical contaminants & pesticides in your HACCP plan. This was a hazard listed in your hazards analysis, though you did not include it as a hazard in your HACCP plan.
    2. Allergens would be considered a hazard during the labeling step of the buffalo fish and should be listed in your HACCP plan.  Fish are considered one of the eight major food allergens and as such must by clearly identified on the label.  A “fish” as defined in 21 CFR 123.3(d) means fresh or saltwater finfish, crustaceans, other forms of aquatic animal life (including, but not limited to, alligator, frog, aquatic turtle, jellyfish, sea cucumber, and sea urchin and the roe of such animals) other than birds or mammals, and all mollusks, where such animal life is intended for human consumption.
    3. The buffalo fish are (b)(4) with a (b)(4) blade and the heading of the fish is done with a (b)(4).  Metal equipment can become a likely source of metal that may enter the food during processing and must be listed as a hazard in your HACCP plan.
  2. Your HACCP plan lists a critical limit that does not ensure control of one or more hazards 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 buffalo fish lists a critical limit of (b)(4) at the Critical Control Point (CCP) (b)(4) that does not ensure the control of bacterial growth.
  3. Your HACCP plan does not list monitoring procedures and frequencies that ensure compliance with the critical limit to comply with 21 CFR 123.6 (c) (4).  However, your HACCP plan for buffalo fish does not list monitoring procedures/frequencies at the Critical Control Point (CCP) (b)(4) that ensures compliance with the critical limit of (b)(4).  The HACCP plan lists a monitoring frequency of (b)(4) to observe the (b)(4) thermometer for the cooler.  This is not an adequate monitoring frequency to ensure the temperature of the cooler.
  4. Your HACCP plan lists verification procedures and frequencies that have not been developed in accordance with 21 CFR 123.8(a) to comply with 21 CFR 123.6 (c) (6).  However, your firm’s HACCP plan titled “Raw Fish”, under the Critical Control Point (CCP) (b)(4), lists a verification of (b)(4) to control the critical limit listed as (b)(4).  This verification has not been developed in accordance with 21 CFR 123.8 (a), in order to ensure that the plan is being effectively implemented.
  5. Your HACCP plan was not signed and dated at least annually to comply with 123.6 (d). However, the last time the HACCP plan for buffalo fish was signed was on “12-8-97”.
  6. 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, you did not monitor the condition and cleanliness of food contact surfaces, prevent cross-contamination from insanitary objects, maintenance of hand washing, hand sanitizing, and toilet facilities, protection of food, and food contact surfaces from adulteration, as evidenced by the following:
    1. Dirty gloves were observed lying directly on the (b)(4) of the (b)(4), used to (b)(4) carp and buffalo fish.
    2. (b)(4) was observed to clean the floor in the processing room.  Water droplets were on the ceiling after washing, above the two-compartment sink and the (b)(4), used to (b)(4) buffalo fish.
    3. Your firm’s restroom consists of one portable toilet facility located on the outside of the building.  The portable toilet facility does not have a hand washing sink. Employees use a two compartment sink located in the facility to wash their hands.  The sink is also used to clean equipment and at times is filled with water, soap, and equipment, making it difficult for employees to properly wash their hands.  Additionally, the sink does not contain disposable towels in their towel dispenser.
  7. You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm did not monitor conditions and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, maintenance of hand washing, hand sanitizing, and toilet facilities, protection of food, and food contact surfaces from adulteration, as required for the processing of your buffalo fish. 
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps that you are taking to correct these violations. You should include in your response documentation such as; HACCP plan revisions, monitoring records, cleaning sanitization records any other information that would assist us in evaluating your corrections.  If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
 
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.
 
This letter may not list all the violations at your facility. As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your processing plant operates in compliance with the Act, and the seafood HACCP regulation (21 CFR Part 123).  You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
 
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including reinspection-related costs from the responsible party of the domestic facility.  A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved.  Reinspection-related costs means 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 [21 U.S.C. 379j-31 (a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility.  The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
Your written response should be addressed to:
 
Lauren Crivellone, Compliance Officer
FDA Chicago District Office
U.S. Food and Drug Administration
550 W. Jackson Blvd., Suite 1500
Chicago, IL 60661 
 
Refer to the Unique Identification Number (CMS Case #518929) when replying. If you have any questions about the content of this letter, please contact Ms. Crivellone via email at lauren.crivellone@fda.hhs.gov or by phone at (312)-596-4157.
 
 
Sincerely,
/S/ 
William R. Weissinger
District Director
           

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