- Delivery Method:
Recipient NameMr. Steven Tucker
- Nautical Foods, LLC
260 A Secaucus Road
Secaucus, NJ 07094
- Issuing Office:
- Baltimore District Office
Baltimore District Office
CMS # 523346
August 24, 2017
VIA UNITED PARCEL SERVICE
Mr. Steven Tucker, COO & Owner
Nautical Foods, LLC
260 A Secaucus Road
Secaucus, New Jersey, 07094
Dear Mr. Tucker:
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 of Listeria 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 insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. Additionally, our inspection found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). In accordance with 21 CFR Part 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 Act. You may find the Act, the seafood HACCP and cGMP regulations, and the 4th Edition of FDA's Fish and Fisheries Products Hazards & Controls Guidance through links on FDA's home page at www.fda.gov.
The FDA investigators provided you with the form FDA-483, List of Inspectional Observations, at the conclusion of the inspection on March 28, 2017, which presents the investigator's observations. As of the date of this letter, we have not received a written response to the FDA-483 observations.
L. monocytogenes is 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 with L. monocytogenes can 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.
FDA's laboratory analysis of environmental sample (INV961739) collected on March 1, 2017, confirmed that five (5) environmental swabs tested positive for L. 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.
Whole Genome Sequence (WGS) analysis was conducted on the five (5) L. monocytogenes isolates 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 of L. monocytogenes. Comparing these five (5) strains to the larger WGS database shows that four (4) of the isolates are virtually identical to twenty eight (28) isolates from sample INV9349892 and 934893 collected in January of 2016 from the same facility. This demonstrates a resident strain of L. monocytogenes has maintained its presence in your facility since at least January of 2016. The presence of a resident strain of L. monocytogenes in your facility is significant in that it demonstrates your sanitation efforts are inadequate to effectively control pathogens in your facility to prevent contamination of food.
Seafood HACCP violations
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 control Clostridium botulinum growth and toxin formation in your refrigerated vacuum packaged finished products. Since your HACCP plan lists refrigeration below (b)(4) as the (b)(4) control for C. botulinum, TTIs should be attached to each individually vacuum packaged finished product to control non-proteolytic C. botulinum throughout the distribution chain. FDA recommends your HACCP plan list critical control point for proper use of the TTIs (e.g., activation, application, etc.) with critical limits based on the manufacturer's information.
2. You must have a HACCP plan that at a minimum, lists the critical limits that must be met, 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 firm's HACCP plans for "Crab Cake & Crab Cake Mix", "RTC Frozen Product other than Crab Cake" and "RTE Seafood Salad" list a critical limit of "(b)(4)" at the labeling critical control point that is not adequate to control for the hazard of undeclared allergens and sulfites. FDA recommends that all finished product labeling accurately list all identified major food allergens (milk, egg, fish, crustacean shellfish, tree nuts, peanut, wheat and soybeans) and sulfating agents that have a functional effect which are included in the product formulation.
Additionally, the labeling critical limit in your firm 's HACCP plan for "RTC Frozen Product other than Crab Cake" is not adequate to control for the hazard of C. botulinum growth and toxin formation. Since your vacuum packaged finished product is frozen, FDA recommends your HACCP plan list a critical limit for proper labeling, such as "Important, keep frozen until used, thaw under refrigeration immediately before use." on each individually vacuum packaged finished product to control non-proteolytic C. botulinum.
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, specifically C. botulinum when 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.
Additionally, Your firm's HACCP plan for "RTE Seafood Salad" lists a monitoring frequency of "(b)(4)" at the defrosting (in a refrigerator) critical control point that is not adequate to control pathogens in your RTE seafood salads. Using a (b)(4) is not adequate because it does not provide a food safety assurance equivalent to a continuous temperature recording device.
Lastly, your fum's HACCP plan for "RTE Seafood Salad" lists a monitoring frequency of "(b)(4)" at the chilling critical control point that is not adequate to control pathogens. FDA recommends monitoring the internal product temperature at least every two hours
4. You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6 (b) and (c)(7). However, your firm did not have HACCP monitoring records for the following seafood products:
5. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21CFR123.7 (b). However, your corrective action plan for "Crab Cake & Crab Cake Mix" at the receiving critical control point to control pathogens is not appropriate because it does not address correcting the cause of the deviation. FDA recommends that in addition to addressing the disposition of the affected food that your corrective actions also list correcting the cause of the deviation such as discontinue use of the supplier until evidence that the transportation practices have been improved.
Additionally, your corrective action plans for "RTE Seafood Salad" at the following critical control points to control pathogens are not appropriate, specifically:
• At the defrosting critical control point the listed corrective action of (b)(4) does not take into consideration that when temperatures exceed 70°F the maximum cumulative exposure time should be limited to 2 hours.
The listed corrective action of food items that have begun the thawing process must be (b)(4) does not control pathogen growth and toxin formation; specifically S. aureus and B. cereus. Both pathogens produce toxins that are not inactivated by normal cooking.
FDA recommends the corrective actions list that the product is chilled and held until an evaluation of the total cumulative time and temperature exposure is performed for food safety. Product disposition should be based on the cumulative total time and temperature exposures for pathogen growth and toxin formation as listed in Table A-2 in Appendix 4 of the Fish and Fishery Product Hazard and Controls Guidance (4th ed.). Additionally, listed corrective actions should include correcting the cause of the deviation such as making repairs to the cooler.
• At the chilling critical control point the listed corrective actions are not adequate because they do not include correcting the cause of the deviation, such as adjustment to the chilling process or refrigerator.
This letter is not intended to be an all-inclusive list of the violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. You are responsible for ensuring that your products are in compliance with the Act and all applicable FDA regulations. You should take prompt action to correct the violations cited in this letter and prevent their recurrence. Failure to properly correct these violations and implement lasting corrective action of these violations may result in regulatory action without further notice, including, without limitation, seizure and injunction.
Your HACCP plan for "RTE Seafood Salad" lists critical limits to control the identified food safety hazard of pathogens that also control the food safety hazard of histamines, which your plan fails to list as a food safety hazard. We recommend that you revise the HACCP plan to also identify the food safety hazard of histamines.
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 re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
You should notify this office in writing within fifteen (15) working days of receiving this letter of the steps you have taken to correct the violations described above and to prevent similar violations in the future. Your response should include documentation to show that correction has been achieved. If corrective action cannot be completed within 15 days, state the reason for the delay and the time frame within which the corrections will be completed.
Your response should be sent to the following address: U.S. Food and Drug Administration, 10 Waterview Blvd., 3rd Floor, Parsippany, New Jersey 07054. If you should have any questions regarding any issue in this letter, please contact Andrew Ciaccia, Compliance Officer, phone number is 973-331-4904.
Baltimore District Director
Program Division Director/
Human and Animal Foods Division II East