Nautical Foods, LLC FDA Warning (2017)

Detailed Analysis

False Claims and Regulatory Violations

L. monocytogenesis a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans, or equipment. Without proper controls, it can proliferate in food processing facilities where it may contaminate food. Consuming food contaminated withL. monocytogenescan lead to a severe, sometimes life-threatening illness called listeriosis; an atypical foodbome illness, which is a major public health concern due to the severity of the disease, its high case-fatality rate, long incubation time, and tendency to affect individuals with underlying conditions.

Whole Genome Sequence (WGS) analysis was conducted on the five (5)L. monocytogenesisolates obtained from the FDA environmental sample collected during our inspection, on March 1, 2017. WGS analysis of bacterial human pathogens provides high-resolution data, enabling direct links to be established between clinical isolates and food or environmental sources of bacterial contamination and illness. WGS data can also be used to infer the evolutionary relationships (or phylogeny) within a given set of isolates as it measures each DNA position in a bacterial genome. The WGS phylogenetic analysis of these five (5) isolates finds that they comprise two (2) strains ofL. monocytogenes. Comparing these five (5) strains to the larger WGS database shows that four (4) of the isolates are virtually identi

1.    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 "Crab Cake & Crab Cake Mix" does not list a critical control point for the use of time temperature indicators (TTis) to controlClostridium botulinumgrowth and toxin formation in your refrigerated vacuum packaged finished products. Since your HACCP plan lists refrigeration bel

Potential Health Risks

The U.S. Food and Drug Administration (FDA) inspected your facility located at 260 A Secaucus Road, Secaucus, New Jersey, on February 28, 2017 through March 28, 2017. During the inspection, FDA collected environmental samples consisting of multiple swabs taken from various areas in your facility, including areas where cross-contamination to food and food contact surfaces is possible. FDA laboratory analysis of the environmental swabs identified the presence ofListeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. We have determined that your ready-to-eat (RTE) seafood products are 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), in that they were prepared, packed or held under insanitar

Regulatory Context

FDA's laboratory analysis of environmental sample (INV961739) collected on March 1, 2017, confirmed that five (5) environmental swabs tested positive forL. monocytogenes. The positive swabs were collected from surface areas in locations where ready-to-eat seafood salads are manufactured and packaged. Specifically, three (3) of these swabs were collected from the packaging area and two (2) were collected from the ready-to-eat kitchen. These areas are in close proximity to food contact surfaces allowing for potential cross-contamination of food contact surfaces and food through the actions of man or machine.

Seafood HACCP violations

3.    You must have a HACCP plan that at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6 (c)(4). However, your firm 's HACCP plan for "Crab Cake & Crab Cake Mix" lists a monitoring frequency of(b)(4)at the receiving critical control point that is not adequate to control pathogens growth and toxin formation, specificallyC. botulinumwhen receiving products such as refrigerated canned pasteurized crab meat. FDA recommends continuous ambient temperature monitoring of the truck to be 40°F or less throughout transit.