- Delivery Method:
- Via Express Delivery
- Food & Beverages
Recipient NameMr. Kabir Kanji
- Mahi Frozen Foods
D1/D2, Fish Harbor, West Wharf
- Issuing Office:
- Center for Food Safety and Applied Nutrition (CFSAN)
August 15, 2022
Dear Mr. Kabir Kanji:
The United States Food and Drug Administration (FDA) conducted a Foreign Remote Regulatory Assessment (FRRA) of your seafood processing facility, Mahi Frozen Foods, located at D1/D2, Fish Harbor, West Wharf Karachi, Sindh, 74400, Pakistan on April 4 – 8, 2022. During the remote assessment, we found that you had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (21CFR Part 123). At the conclusion of the assessment, the FDA investigator discussed items of concern. We received your response on April 14, 2022, including a revised HACCP plan. We reviewed the documentation and continue to have serious concerns with your current HACCP program as further described in this letter.
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 fish fillet products are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation, and the 4th Edition of the Fish and Fisheries Products Hazards & Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.
Your significant deviations are as follows:
1. You must conduct or have conducted for you 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 “Fish Fillets” does not list the food safety hazard of ciguatera fish poisoning (CFP). Specifically, your firm processes several species of fish (unicorn fish, grouper, red snapper, and amberjack) which have been associated with CFP.
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 “Fish Fillets” does not list critical control points for the following processing steps:
a. At the “(b)(4)” step to control the food safety hazard of scombrotoxin (histamine) formation. Your firm receives mahi-mahi and amberjack from local fishermen. You then transport the fish approximately one hour from the vessels and docks to your processing facility. Your hazard analysis incorrectly identified the “(b)(4)” step as an Operational Prerequisite Program (OPRP) and did not consider the receiving of the fish at offloading and after transportation of the fish from the offloading location to the processing facility.
FDA recommends your HACCP plan identifies controls (i.e., critical limits, monitoring procedures) for receiving the fish at the dock and at the processing location as a critical control point. Recommended controls include, examining harvest vessel records to ensure that incoming fish were properly handled and adequately chilled onboard the harvest vessels and during transit, checking incoming fish to ensure that they are not at an elevated temperature at time of receipt, performing sensory examination of incoming fish to ensure that they do not show signs of decomposition and testing incoming fish for histamine levels. We note that your OPRP plan list critical limits for some of these controls that may not provide an equivalent assurance of safety. Specifically:
i. Your OPRP plan’s critical limit of “(b)(4)” is not adequate to control scombrotoxin formation. This critical limit is for fish held iced or refrigerated (not frozen) onboard the harvest vessel from 12 to less than 15 hours after death. Your firm receives fish from harvest vessels that could potentially hold the iced fish up to one week before returning to port. For fish held iced or refrigerated (not frozen) onboard the harvest vessel 24 or more hours after death, the internal temperature should be 40°F (4.4°C) or below at receipt. In addition, your plan’s monitoring procedures should ensure that internal temperatures are recorded during off-loading.
ii. Your OPRP plan’s critical limit of “(b)(4)” states, “(b)(4).” Since lots vary in size, FDA recommends that sensory examination of a representative sample of scombrotoxin-forming fish shows decomposition (persistent and readily perceptible odors) in less than 2.5% (<2.5%) of the fish in the sample. Note that the FFD&C Act prohibits interstate commerce of any decomposed fish whether or not the HACCP critical limit has been exceeded.
Additionally, your firm transports the fish you buy from the harvest vessels or docks to your processing facility. Your OPRP plan does not include a critical limit for internal temperatures to ensure the fish were held at or below an ambient or internal temperature of 40°F (4.4°C) throughout transit and that time of transit does not exceed 4 hours. These controls should be considered when revising your HACCP (CCP) plan.
b. At the “(b)(4)” step to control the food safety hazard of scombrotoxin (histamine) formation. Specifically, your hazard analysis incorrectly identified this step as a prerequisite program. FDA regulations do not allow replacement of critical control points with prerequisite programs as an alternative to listing controls in a seafood HACCP plan. Your firm processes mahi-mahi and amberjack, both of which are histamine-forming fish. Your firm’s Process Description describes, “(b)(4)” and, “(b)(4).” Our investigator was told that the soaking process could take up to 24 hours. The “(b)(4)” step should be identified as a critical control point in your revised HACCP plan to prevent histamine formation.
During processing of scombrotoxin-forming fish or fishery products that have not been previously frozen or heat processed sufficiently to destroy scombrotoxin-forming bacteria, FDA recommends:
i. That the fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 4 hours, cumulatively, if any portion of that time is at temperatures above 70°F (21.1°C);
ii. That the fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 8 hours, cumulatively, so long as no portion of that time is at temperatures above 70°F (21.1°C).
Your firm has the option of maintaining ambient temperatures below 40°F (4.4°C) during the “(b)(4)” step or controlling cumulative exposure times to ensure fish are not exposed to ambient temperatures above 40°F (4.4°C) as described above. When establishing critical limits at this processing step, you should consider all cumulative exposure times that can occur in multiple processing steps where fish are exposed to ambient temperatures above 40°F (4.4°C). This may require additional critical control points to control overall cumulative exposure times. According to your firm’s Process Description, there is potential for scombrotoxin-forming fish to be exposed to ambient temperatures above (b)(4)°F (b)(4)°C) during the “(b)(4),” “(b)(4),” “(b)(4),” “(b)(4),” and “(b)(4)” steps and your HACCP plan does not address cumulative time and temperature exposures.
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 deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan or plans, five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of 5 production date codes of products) to demonstrate implementation of the plan, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the seafood HACCP regulation. 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. If you believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration.
If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported fish or fishery products under section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation is Import Alert 16-120. This alert can be found on FDA’s web site at: http://www.accessdata.fda.gov/cms_ia/importalert_25.html.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the seafood HACCP regulation (21 CFR Part 123) and the current Good Manufacturing Practice Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117 Subpart B). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
In addition to the deviations listed above, we have the following comment:
Your OPRP processing steps list monitoring procedures that will not provide safety assurances equivalent to FDA’s safety recommendations. FDA recommends a minimum of 12 fish of each species received be monitored for internal temperature at offloading to control scombrotoxin formation or the entire lot of fish if less than 12 fish are received. Your OPRP plan does not identify how many fish in each lot will be examined. FDA recommends a minimum of 18 fish from each species received be monitored for internal temperature at offloading to control scombrotoxin formation or the entire lot of fish if less than 18 fish are received.
Please send your reply to the Food and Drug Administration, Attention: Alyssa Piontkowski, Compliance Officer, Office of Compliance, Division of Enforcement, Food Adulteration and Assessment Branch (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding any issues in this letter, please contact Alyssa Piontkowski via email at: Alyssa.Clendenin@fda.hhs.gov. Please include reference #637152 on any submissions and within the subject line of any email correspondence to the agency.
Ann M. Oxenham
Office of Compliance
Center for Food Safety and Applied Nutrition