- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Food & Beverages
Recipient NameMr. Abraham Attias
Recipient TitlePresident and Co-Owner
- Banner Smoked Fish Inc.
2715 West 15th Street
Brooklyn, NY 11224-2705
- Issuing Office:
- Office of Human and Animal Food Operations East – Division 1
CMS # 616015
November 8, 2021
Dear Mr. Attias and Mr. Levitz:
The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) cold- and hot-smoked seafood processing facility located at 2715 West 15th Street, Brooklyn, NY 11224-2705, on May 5, 10, 12, 21, 24, and 26, and June 7, 8, 9, and 21, 2021. During our inspection we collected environmental samples (swabs) from various areas in your facility, including areas that are near food during processing operations and food-contact surfaces of your facility. FDA laboratory analyses of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. Additionally, FDA found serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (CFR), Part 123 (21 CFR Part 123).
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). Based on our inspectional results, including review of FDA’s environmental testing and your HACCP plan, we have determined that your RTE seafood products are adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4), in that they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. You may find the Act, the Seafood HACCP regulation, and the 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance through links in FDA’s home page at www.fda.gov.
At the conclusion of the inspection, the FDA investigators issued your facility a Form FDA 483 (FDA-483), Inspectional Observations. You provided responses to the inspection and sample findings via email on June 2, 3, and 22, 2021 and July 12 and 28, 2021 which included corrective actions taken by your firm. We have reviewed the documentation and continue to have serious concerns with your current HACCP programs as further described in this letter.
Presence of L. monocytogenes
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. Therefore, it is essential to identify the areas of the food processing plant where this organism is able to grow and survive and to apply controls or take corrective actions as necessary to eradicate the organism. Consuming foods contaminated with L. monocytogenes can lead to a severe, sometimes life-threatening illness called listeriosis, which is a major public health concern due to the severity of the disease, its high case-fatality rate, its long incubation time, and its tendency to affect individuals with underlying conditions.
FDA laboratory analysis of the environmental sample 1154266 collected on May 5, 2021, from various areas in your processing facility, including food-contact surfaces and areas adjacent to food-contact surfaces, confirmed that seven (7) out of one hundred one (101) environmental swabs collected were positive for L. monocytogenes. Of the positive findings, two (2) swabs were collected from the following food-contact surfaces: a wax paper lining on a metal tray that was holding RTE cold-smoked salmon prior to packaging and the surface of a spoon that was used to clean belly portions of whole salmon intended to be cold smoked. Additionally, five (5) swabs were found positive for L. monocytogenes on areas directly adjacent to food-contact surfaces including a scale used to weigh trays of RTE cold-smoked salmon.
Furthermore, this was not the first time FDA investigators collected environmental samples from your facility that were found to be positive for L. monocytogenes. Environmental sample 1105252 collected on December 3, 2019 confirmed two (2) out of one hundred eight (108) swabs collected were positive for L. monocytogenes. These positive findings were collected from the wheels of a cart containing trays of RTE cold-smoked salmon located in the slicing room and a table leg of a cold-smoked product slicer.
Whole genome sequencing (WGS) was conducted on seven (7) L. monocytogenes isolates obtained from the FDA environmental sample collected on May 5, 2021 and two (2) L. monocytogenes isolates obtained from the FDA environmental sample collected on December 3, 2019. The current WGS analysis determined that the isolates derived from the samples collected at your facility, referenced above, represent six (6) different strains of L. monocytogenes. One of these strains, from the environmental sample collected from your facility on May 5, 2021 is a genomic match to a clinical isolate collected from an ill person, which indicates that this strain has the capability of causing human illness. We advised you of the WGS results via a conference call on June 1, 2021.
Appropriate control of L. monocytogenes in a food processing environment requires knowledge of the unique characteristics of the organism and the corresponding hygienic practices necessary to control this pathogen. Our findings indicate that your firm is neither achieving satisfactory control against the presence of L. monocytogenes within your facility nor implementing effective methods and controls to eliminate this human pathogen or minimize exposure to food and food-contact surfaces. Once it is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. It is essential to identify the harborage sites in the food processing plant and equipment where this organism is able to grow and survive and to take such corrective actions as are necessary to eradicate the organism.
Your written responses outline the corrective actions you have taken to address our L. monocytogenes findings within your environment. Your response states that when you were initially made aware of our environmental findings you conducted a voluntary recall, ceased manufacturing operations, and disposed of product in storage at your facility. Additionally, you retained a food safety consultant to assist in performing a root cause investigation and developing plans for implementing the appropriate corrective actions. Your described corrective actions included deep cleaning and sanitizing of facility and equipment, updating your sanitation procedures and environmental monitoring program, conducting facility repairs which include addressing the hygienic design and traffic flow, conducting environmental testing on food-contact and non-food contact surfaces to verify your corrective actions, and conducting employee training for your updated programs and procedures. We note that your revised “Listeria Sampling Program” does not clarify whether environmental samples will be analyzed for Listeria spp. and/or L. monocytogenes and does not provide the specific method of analysis. Your response to this Warning Letter should include a revised “Listeria Sampling Program.” Additionally, we will further verify the adequacy and implementation of your corrective actions during a future inspection.
Your significant deviations are as follows:
1. You must monitor the conditions and practices during processing with sufficient frequency to ensure, at a minimum, conformance with those conditions and practices specified in 21 CFR 117, Subpart B (CGMPs), that are appropriate to your plant and the food being processed and relate to one of the areas specified in 21 CFR 123.11(b)(1)-(8), to comply with 21 CFR 123.11(b). Specifically:
A. You failed to monitor the conditions and practices during processing with sufficient frequency to ensure that cleaning and sanitizing of utensils and equipment was conducted in a manner that protected against contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 117.35(a). This is related to the condition and cleanliness of food-contact surfaces, 21 CFR 123.11(b)(2). Specifically,
i. The outdoor lot behind your facility was used as an area to clean rolling racks that hold in-process and finished RTE cold-smoked products. Employees were observed using high-pressure hoses to clean rolling racks in the rain while standing in pools of accumulated rinse and rainwater, both of which were observed coming into direct contact with the equipment. Note that high-pressure hoses create overspray and aerosols that can transfer and spread pathogens from pools of filth and pathogens on the ground to food contact surfaces. In addition, the outdoor lot is used to store refuse, such as cardboard and foam containers previously used to hold raw fish, and racks were observed placed directly onto the ground. These racks are transported throughout the facility including RTE areas of your plant.
ii. Employees were observed using high-pressure hoses to clean white tubs marked as ‘edible’ which were intended to store RTE cold-smoked fish. While cleaning, these tubs were placed directly on the floor, adjacent to litter and other items intended for the dumpster. Furthermore, FDA detected L. monocytogenes in Sub Sample #90 on the floor adjacent to this area where the tubs were cleaned.
iii. Brushes in the slicing room were noted to be visibly dirty with apparent cold-smoked salmon particles in the bristles. These brushes were later used to conduct cleaning operations of equipment located in the slicing room, including a stainless steel packing table.
iv. An employee was observed to drop a knife used to trim RTE cold-smoked salmon onto the floor and then to spray the knife with an (b)(4) solution. The knife was returned to service to pack RTE cold-smoked salmon slices without cleaning and sanitizing. Use of (b)(4) does not kill or eliminate pathogens such that cleaning and sanitizing is not necessary.
B. You failed to monitor the conditions and practices during processing with sufficient frequency to ensure effective measures were taken to protect finished food from allergen cross-contact and from contamination by raw materials, other ingredients, or refuse, as required by 21 CFR 117.80(c)(6). This is related to the prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, 21 CFR 123.11(b)(3). Specifically, exposed RTE cold-smoked salmon was observed coming into direct contact with double doors as the product was moved from packaging/slicing room on rolling racks. Rolling racks are not covered during transport, and the exposed RTE product was observed to be hanging off the edge of the trays. Furthermore, double doors throughout the facility were observed to be soiled and in poor condition.
C. You failed to monitor the conditions and practices during processing with sufficient frequency to ensure that your plant’s plumbing was adequately maintained to provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor, as required by 21 CFR 117.37(b)(4). This is related to the prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, 21 CFR 123.11(b)(3). Specifically, FDA investigators observed that the floor drain in the slicing/packaging room was backed up and was not adequately draining during cleaning operations. Approximately ½ inch of standing water was observed while an employee used a plunger to clear out the drain directly adjacent to previously cleaned equipment. This plunger was observed stored adjacent to open bottles of barbecue sauce stored in the room earlier in the day.
D. You failed to monitor the conditions and practices during processing with sufficient frequency to ensure that buildings, fixtures, and other physical facilities of the plant were maintained in a clean and sanitary condition, as required by 21 CFR 117.35(a). This is related to the prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, 21 CFR 123.11(b)(3), and the protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants, 21 CFR 123.11(b)(5). Specifically,
i. Floors throughout your facility were observed with standing water, cracks, pits, and crevices. Exposed aggregate was observed under the GEBA slicer used to process RTE cold-smoked salmon. Additionally, multiple areas of concrete were noted to be heavily damaged where rebar support underneath is exposed, including the area adjacent to Cooler (b)(4). The drain in close proximity to this exposed rebar near Cooler (b)(4) was found positive for L. monocytogenes (Sub Sample #101).
ii. Walls of your facility, adjacent to Cooler (b)(4) and Cooler (b)(4), had portions of spray foam insulation that were damaged. Additionally, apparent black mold was observed on the damaged spray foam insulation.
E. You failed to monitor the conditions and practices during processing with sufficient frequency to ensure that drip or condensate from fixtures, ducts and pipes does not contaminate food, as required by 21 CFR 117.20(b)(4). This is related to the protection of food from adulteration with condensate, 21 CFR 123.11(b)(5). Specifically, FDA investigators observed condensate dripping from an air-conditioning unit directly onto freshly butchered and salted RTE salmon in the butchering/wet room that was intended to be cold smoked and directly onto RTE cold-smoked salmon trimmings held in an open cardboard box in the slicing/packaging room intended for sale.
F. You failed to monitor the conditions and practices during processing with sufficient frequency to ensure that toxic cleaning compounds were stored in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 117.35(b)(2). This is related to the proper storage of toxic compounds, 21 CFR 123.11(b)(6). Specifically, FDA investigators observed open containers of cleaning compounds in Cooler (b)(4), which contained exposed racks of hot-smoked mackerel and cold-smoked salmon.
Your responses dated July 12, 2021 and July 28, 2021 stated that you have made corrections including that you have redesigned your facility with “proper flow” and provided an updated process flow diagram. You developed new sanitation standard operational procedures (SSOPs) and sanitary handling procedures. These updated procedures indicate that rolling racks and white tubs will be cleaned in a designated wash area, that all cleaning brushes will be stored in designated sanitizer buckets when not in use, all food contact surfaces will be rewashed and sanitized before use when they are contaminated during operation, and all cleaning chemical bottles will be labeled and sealed at all times. You stated that you have made facility improvements including repairing and/or replacing all double doors and framework, adjusting the drain pipes on the refrigeration units to address the condensate issues, and cleaning and sanitizing walls and ceilings in the coolers. Additionally, you indicated that the root cause of the drain backup was blocked lines, which were water jet cleaned by a professional company to remove the buildup inside the drain pipeline, as further addressed in your sanitary handling procedure. Furthermore, you stated that you have dedicated staff for sanitation inspections and for daily maintenance of food safety programs, and that employees were trained on these new procedures.
However, your Pre-Operational (Raw and RTE) and Operational Inspection Forms submitted as part of your July 12, 2021 response, for sanitation monitoring, are not adequate to ensure compliance with CGMP requirements because each form only provides space to indicate monitoring (b)(4). Appropriate sanitation monitoring frequency is dependent upon the length of processing, but at a minimum, it is recommended that monitoring occur before, during, and after processing, with some conditions being monitored every (b)(4), as appropriate. Your response to this warning letter should provide five days’ worth of recently completed and revised sanitation monitoring records to demonstrate implementation of your above listed corrective actions and compliance with 21 CFR 123.11(b). Your revised sanitation monitoring records should include an increased frequency of monitoring and the name of the cleaners and sanitizers along with actual concentrations used and any other important values (e.g., contact time, as appropriate). For assistance with revising your sanitation monitoring records, you may wish to review a document titled “Sanitation Control Procedures for Processing Fish and Fishery Products,” developed by the National Seafood HACCP Alliance for Training and Education, and available at https://www.flseagrant.org/seafood/haccp/.
Furthermore, your firm’s revised HACCP plan lists the use of (b)(4) during the brining of a large variety of fish species including, cod, trout, and mackerel. (b)(4) may only be used on specific species of fish and at concentrations in accordance with either 21 CFR 172.175 for sablefish, salmon, and shad or 21 CFR 172.177 for chub. There are no regulated uses for (b)(4) on other species of fish including cod, trout, and mackerel. Therefore, based on the usage of (b)(4) in fish species that are not listed in 21 CFR 172.177 and 21 CFR 172.175, your response does not ensure chemical food additives and sanitizers are safe and appropriate for use with seafood.
We will further verify the adequacy and implementation of your corrective actions during a future inspection.
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 plan for RTE cold-smoked fish lists a critical limit of "when municipal water temperature is (b)(4) but (b)(4), thawing time not to exceed (b)(4)” at the thawing critical control point. Your firm’s critical limit for RTE cold-smoked fish at the thawing critical control point is not adequate to control the food safety hazard of pathogenic bacteria growth and toxin formation as a result of time and temperature abuse. Cold-smoked fish is considered a raw RTE product that must have appropriate time and temperature controls. FDA recommends when thawing RTE seafood in water at (b)(4) that the product exposure time does not exceed (b)(4). Alternatively, your HACCP plan could list a critical limit and monitoring procedures that ensure the thawing of your RTE fish occurs under refrigeration at (b)(4) or below with continuous temperature monitoring.
The need to revise your current critical limit and properly monitor your revised critical limit is emphasized by our inspectional findings. During a records review, our investigators found that your “Cold Water Temperature 2020” and “DAILY COLD-SMOKE THAW & BRINE LOG” for cold-smoked fish indicated that fish was thawed for (b)(4) from (b)(4). The municipal water temperature on those days was recorded as (b)(4), respectively, and no corrective actions were recorded.
Your July 12, 2021 response included a revised HACCP plan for smoked fish that now lists a critical limit of “Running water from thawing tank is (b)(4)” at the “Thawing in cooler” critical control point. FDA recommends monitoring the running water with continuous temperature monitoring. Your response to this warning letter should include a revised HACCP plan and five days’ worth of critical control point monitoring records for thawing to demonstrate implementation of revisions. Additionally, we will further verify the adequacy and implementation of your corrective actions and HACCP plan during a future inspection.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing the recurrence or occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
You should take prompt action to address the violations noted in this letter. Failure to promptly address these violations may result in legal action without further notice; including, without limitation, seizure and injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
In addition to the violations described above, we offer the following comment:
Your firm’s revised HACCP plan included a Flow Diagram that states “(b)(4)” is used. Any substance added to food needs to be authorized by a food additive regulation, effective food contact notification (FCN), or be generally recognized as safe (GRAS) for the intended use. There is no FDA regulation nor effective FCN allowing use of peracetic acid (also known as peroxyacetic acid, CAS Reg. No. 79-21-0) directly on seafood. There are FCNs (e.g., FCN Nos. 699, 1081, 1093, 1144, 1247, 1284, 1362, 1389) for use of PAA mixtures as an (b)(4) agent in wash water and/or ice used in preparation of seafood. Please note that FCNs are only effective for the notifier and their manufacturer/supplier. For example, if you are purchasing your food contact substance from a manufacturer or supplier who has their own effective FCN for that use, use of their formulation would be authorized. We recommend that you provide additional information on how PAA is being used in your operations, including the legal basis for its use.
Section 743 of the Act, (21 USC 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 USC 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 noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Please notify this office in writing within 15 working days of receipt of this letter, of the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the time frame within which you will do so.
Please send your reply to the U.S. Food and Drug Administration, Attention: Scott M. Loughan, Compliance Officer, 462 Welcome Center Road, Swanton, VT 05488 or via email (preferred) to Scott.Loughan@fda.hhs.gov. If you have questions regarding any issues in this letter, please contact Mr. Loughan at 802-868-4725 or Scott.Loughan@fda.hhs.gov.
Ronald M. Pace
Program Division Director
Office of Human and Animal Food Operations
East – Division 1