A seafood processing facility in Flushing, NY, is on a note from the FDA for serious violations of federal law, including filthy situations, insufficient refrigeration management, and the potential for botulism toxin to increase in products. A July 16 warning letter made public in the latest days gave Dian Yan Lin, AB Seafood Trading Inc president.
Three hundred fifteen days to accurately address the troubles and reply in writing to the Food and Drug Administration concerning the food safety troubles. The FDA caution letter cites observations using inspectors inside the facility on May 15, 17, and 24. That inspection found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) law, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123).
“Accordingly, your refrigerated and uncooked, geared up-to-devour seafood merchandise inclusive of tuna, Spanish mackerel, salmon, sea bass, trout, fluke, amberjack, and vacuum packaged yellowtail (Hamachi) are adulterated, in that they have been organized, packed, or held beneath insanitary conditions whereby they will be rendered injurious to health,” in step with the caution letter. “Your substantial violations are as follows (ambitious kind — (b)(four) — suggests facts withheld from public view by way of the FDA):
1. You should change behavior or have performed for you a chance analysis for every kind of fish and fishery product that you produce to decide whether there are food protection hazards that might be fairly possibly to occur and feature a HACCP plan that, at a minimum, lists the meals protection risks which can be moderately possibly to arise, to comply with 21 CFR 123.6(a) and (c)(1). A food safety threat is defined in 21 CFR 123.3 (f) as “any biological, chemical, or bodily belongings which can purpose meals to be dangerous for human consumption.” However, your firm’s HACCP plan for uncooked, refrigerated salmon, sea bass, trout, fluke, and mackerel is supposed to be fed on raw, ready-to-devour without; also, cooking does no longer listing the food protection threat of parasites.
2. You must have a HACCP plan that, at a minimum, lists the important limits that must be met to comply with 21 CFR 123.6 (c)(three). An important restriction is described in 21 CFR 123. Three (c) is “the most or minimal price to which a physical, biological, or chemical parameter must be managed at a critical manipulate point to prevent, do away with, or lessen to an acceptable stage the incidence of the diagnosed food safety threat.”
However, your company’s HACCP plan for refrigerated, raw, ready-to-eat, vacuum-packed yellowtail (Hamachi) lists an important restriction of: “Temperature remains underneath (b)(4)°, F or (b)(4) which maintain the inner temperature of product (b)(4)°F or (b)(4)” on the receiving vital manipulate factor that does not ensure the control of Clostridium botulinum toxin formation threat. In exercise, you get hold of this product with (b)(4) and Time-Temperature Indicators (TTI’s) (b)(four) yellowtail (Hamachi), and as such, FDA currently recommends the subsequent: TTI attachment and activation; Adequate quantity of cooling media that stay frozen to have maintained product at 40° F (4.4° C) or underneath in the course of transit; The internal temperature of the product on the time of delivery is forty° F (4.4° C) or under.
3. You have to put in force the monitoring approaches and frequency that you have listed on your HACCP plan to comply with 21 CFR 123.6(b) and (c)(four). However, your firm did not observe the monitoring process of “(b)(4) the records will be (b)(4) recorded.
The operation manager is responsible for checking the statistics (b)(four)” listed on the Refrigerated Storage Critical Control Point (CCP) to manipulate the following hazards: pathogen increase and toxin formation to your uncooked, ready-to-consume salmon, sea bass, trout, fluke, mackerel, tuna, and vacuum packaged yellowtail (Hamachi); scombrotoxin (histamine) formation in your raw, equipped-to-consume tuna, mackerel, and vacuum packaged yellowtail (Hamachi); and Clostridium botulinum toxin formation for your refrigerated, basic, prepared-to-devour, vacuum-packed yellowtail (Hamachi).
In exercise, you no longer monitor the recorded facts for your continuous-time and temperature monitoring device used to screen the cooler temperature for the cooler (b)(4), where uncooked, prepared-to-consume fish are saved, and for cooler (b)(four) where raw, ready-to-devour tuna and salmon are processed and stored. This is further obvious by an assessment of your continuous temperature-recording tracking information by our investigators throughout the modern inspection that discovered that the import restriction, at the Refrigerated Storage CCP, of “Maximum cooler temperature (b)(four)° F” was not usually met and no corrective motion turned into taken.
Four. You need to reveal sanitation situations and practices at some stage in processing with enough frequency to make certain compliance with modern-day good production exercise necessities in 21 CFR Part 117, to conform with 21 CFR 123.Eleven(b). However, your company did now not screen the situation and cleanliness of meals contact surfaces, prevention of cross-infection from unsanitary objects, the safety of meals, food packaging material, and meals touch surfaces from impurity, and exclusion of pests with enough frequency to ensure compliance with the cutting-edge suitable production practice requirements in 21 CFR Part 117 as evidenced by using: