Quality Fisheries dba The Niota Fish Market FDA Warning (201

Detailed Analysis

False Claims and Regulatory Violations

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.

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:Dirty gloves were observed lying directly on the(b)(4)of the(b)(4), used to(b)(4)carp and buffalo fish.(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)buf

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.

Potential Health Risks

Consumers should be aware of potential risks associated with products from Quality Fisheries dba The Niota Fish Market.

Regulatory Context

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.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.Allergens would

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.

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.