As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems. The FDA frequently redacts parts of warning letters posted for public view.
Ebenezer International Food LLC
South Burlington, VT
An import company in Vermont is on notice from the FDA for not having FSVPs for a number of imported food products.
In an Aug. 30 warning letter, the FDA described a May 5, 2021, Foreign Supplier Verification Program (FSVP) inspection of Ebenezer International Food LLC in South Burlington, VT.
The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a.
The firm did not develop, maintain, and follow an FSVP for any of the foods they import, including the following foods:
- Grounded cassava leaves imported from (redacted)
- Cut sweet potato leaves imported from (redacted)
- Cut sorrel leaves imported from (redacted)
The FSVP requires importers to verify that their foreign suppliers of food for human and animal consumption meet applicable FDA safety standards.
The full warning letter can be viewed here.
Banner Smoked Fish Inc.
A food firm in New York is on notice from the FDA for serious violations of Seafood Hazard Analysis and Critical Control Point (HACCP) regulation. At least one person has been sickened by product(s) from the facility.
In a Nov. 8 warning letter, the FDA described inspections on May 5,10, 12, 21, 24 and 26, and June 7-9 and 21, 2021, of Banner Smoked Fish Inc.’s ready-to-eat (RTE) cold- and hot-smoked seafood processing facility in Brooklyn, NY.
The FDA’s inspection revealed that the firm was not in compliance with FDA regulations and resulted in the issuance of an FDA Form 483.
Presence of Listeria monocytogenes
FDA laboratory analysis of the environmental sample 1154266 collected on May 5, 2021, from various areas in the firm’s processing facility, including food-contact surfaces and areas adjacent to food-contact surfaces, confirmed that seven out of 101 environmental swabs collected were positive for Listeria monocytogenes. Of the positive findings, two 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 swabs were found positive for Listeria monocytogenes on areas directly adjacent to food-contact surfaces including a scale used to weigh trays of RTE cold-smoked salmon.
Whole genome sequencing (WGS) was conducted on seven Listeria monocytogenes isolates obtained from the FDA environmental sample collected on May 5, 2021, and two Listeria monocytogenes isolates obtained from the FDA environmental sample collected on Dec. 3, 2019. The current WGS analysis determined that the isolates derived from the samples collected at the facility, referenced above, represent six different strains of Listeria monocytogenes. One of these strains, from the environmental sample collected from their 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.
- The firm must monitor the conditions and practices during processing with sufficient frequency to ensure, at a minimum, conformance with those conditions and practices that are appropriate to their plant and the food being processed.
- The firm 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. This is related to the condition and cleanliness of food-contact surfaces.
- The outdoor lot behind their 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 on the ground. These racks are transported throughout the facility including RTE areas of the plant.
- 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 Listeria 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.
- 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 (redacted) solution. The knife was returned to service to pack RTE cold-smoked salmon slices without cleaning and sanitizing. Use of (redacted) does not kill or eliminate pathogens such that cleaning and sanitizing is not necessary.
- The firm 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. This is related to the prevention of cross-contamination from unsanitary objects to food, food packaging material, and other food contact surfaces. 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.
- The firm failed to monitor the conditions and practices during processing with sufficient frequency to ensure that their 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. This is related to the prevention of cross-contamination from unsanitary objects to food, food packaging material, and other food contact surfaces. 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.
- The firm 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. This is related to the prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, 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. Specifically,
- Floors throughout the firm’s 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 (redacted). The drain in close proximity to this exposed rebar near Cooler (redacted) was found positive for L. monocytogenes (Sub Sample #101).
- Walls of the facility, adjacent to Cooler (redacted) and Cooler (redacted), had portions of spray foam insulation that were damaged. Additionally, apparent black mold was observed on the damaged spray foam insulation.
- The firm 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. This is related to the protection of food from adulteration with condensate. 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.
- The firm 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. This is related to the proper storage of toxic compounds. Specifically, FDA investigators observed open containers of cleaning compounds in Cooler (redacted), which contained exposed racks of hot-smoked mackerel and cold-smoked salmon.
The firm’s revised HACCP plan included a Flow Diagram that states “(redacted)” 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, directly on seafood. There are FCNs for use of PAA mixtures as a (redacted) 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 the firm is purchasing their 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 the firm provide additional information on how PAA is being used in their operations, including the legal basis for its use.
The full warning letter can be viewed here.
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