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.
Banks Square Market Corp. dba The Produce Connection
Wakefield, MA
A food firm in Massachusetts is on notice from the FDA for serious violations, including Listeria monocytogenes in its facility.
In a Sept. 2, 2022, warning letter the FDA described a Feb. 8 through March 21, 2022, inspection of Banks Square Market Corp.’s ready-to-eat (RTE) fresh-cut fruit and vegetable processing facility in Wakefield, MA.
The FDA’s inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation and resulted in the issuance of an FDA Form 483. Some of the significant violations are as follows:
Hazard Analysis and Risk-Based Preventive Controls:
1. The firm did not identify and implement preventive controls adequate to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by their facility will not be adulterated or misbranded.
Their hazard analysis for “Diced And Sliced Fruit,” dated Jan. 12, 2022, identified pathogens including L. monocytogenes as a hazard requiring a preventive control for various processing steps such as “(redacted)“, “(redacted)“, and “(redacted)”. Their hazard analysis further stated that “Good Manufacturing Practices/ Sanitation Program/ Training” are the measures taken to apply their sanitation preventive control of “Post wash – Documented sanitation procedure to ensure food contact surfaces post-treatment for RTE product”. However, this preventive control did not ensure the facility was maintained in a sanitary condition adequate to significantly minimize or prevent the hazard of recontamination with environmental pathogens.
FDA laboratory analysis of the environmental sample 1119291 collected on Feb. 8, 2022, from various areas in their processing facility confirmed 8 of 56 environmental swabs were positive for L. monocytogenes. Of the positive findings, 3 swabs were collected from food-contact surfaces where RTE cantaloupe and RTE sliced apples were being prepared, including:
- Surface of the stainless-steel fruit table used for coring apples
- Blade of the yellow knife used to cut cantaloupe
- Green squeegee used for wiping the surface of the stainless-steel table where cantaloupes were being processed
In addition, L. monocytogenes was found on a tote used for holding bulk/whole cantaloupe.
Whole genome sequencing (WGS) was conducted on the above-referenced L. monocytogenes isolates obtained from the FDA environmental sample. The WGS analysis determined that the 8 environmental isolates represented 3 strains of L. monocytogenes. Most notably, two of these strains are genetically identical to clinical isolates, which indicates these strains have the capability of causing human illness. The first of these strains was identified in two environmental isolates collected from their firm and is a match to a clinical isolate from 2019 and a match to 3 other environmental isolates from other sources. The second strain was identified in one environmental isolate and matches a clinical isolate from 2019. Additionally, a third strain identified in 5 environmental isolates matches a 2021 environmental isolate from Florida, but no clinical isolate.
In addition to finding L. monocytogenes in their plant, during the current inspection FDA detected non-pathogenic Listeria species, in environmental samples collected from their firm. FDA laboratory analysis of the environmental sample 1119291 collected on Feb. 8, 2022 confirmed 2 swabs positive for Listeria spp. These swabs were collected from the surface of a floor mat on the side of a fruit cart (Sub #15) and the underside of a shelf on a cart used to hold sliced apples (Sub #23). The presence of non-pathogenic species of Listeria indicates that conditions are suitable for survival and/or growth of L. monocytogenes in the locations where they are found.
Furthermore, during the current inspection, investigators observed employee handling practices that could lead to cross-contamination of food-contact surfaces and RTE food products. The FDA also noted that they previously informed the firm of their concerns related to cross-contamination during a 2019 inspection of their facility. Specifically, during the current inspection, they observed the following:
- On Feb. 8, 2022, employees peeled, sliced, and packaged apples in lot # (redacted), and then handled chipped and broken food waste containers and garbage cans, without changing their gloves or washing and sanitizing their hands prior to returning to (redacted) processing RTE apples. FDA environmental swab (Sub #17) was collected from the outside rim and chipped surface area of the green 50-gallon plastic barrel being used to discard apple cores in the fruit processing area during this time period and found positive for L. monocytogenes.
- On Feb. 8, 2022, employees peeled, sliced, and packaged RTE cubed cantaloupe in lot # (redacted), and then handled food waste containers, garbage cans, and plastic totes, without changing their gloves or washing and sanitizing their hands prior to returning to processing RTE cantaloupe. FDA environmental swab (Sub #35) was collected from the exterior surface of the tote used for holding the bulk/whole cantaloupe during processing and found positive for L. monocytogenes.
- On Feb. 8, 2022, employees used a green squeegee to wipe food-contact surfaces of a table after processing RTE cantaloupe and then immediately processed pineapple on the same table. FDA environmental swab (Sub #30) was collected from the green squeegee during processing and found positive for L. monocytogenes.
On Feb. 28, 2022, after FDA reported the positive L. monocytogenes environmental sample results, they stated that they ceased fruit production that did not have “(redacted)” and began their root cause investigation. During that time, they also stated that cantaloupe lot # (redacted) and apples lot # (redacted) had expired, as their RTE cut fruit products have a shelf life of 7-10 days. They also reported that their firm conducted cleaning and sanitizing of processing tables and equipment beyond their normal sanitation procedures; reswabbed the positive environmental sample locations; and began identifying and implementing corrective actions in response to the environmental sample findings.
Current Good Manufacturing Practice:
1. The firm did not clean their non-food contact surfaces in a manner and as frequently as necessary to protect against contamination of food, food-contact surfaces, and food-packaging materials, as required. Specifically, FDA investigators observed the following:
- On Feb. 10, 2022, an employee used a high-pressure hose that had contacted the floor before use and sprayed the rear wall of the main production facility during production of RTE romaine lettuce. The spray from the hose was observed contacting the floor several times and creating an aerosol and mist within the production area that was also visible in the air several feet away from the RTE romaine that was processed. Note that high-pressure hoses create overspray and aerosols that can transfer and spread pathogens from the environment to food contact surfaces, and floors are common sources of environmental pathogens such as L. monocytogenes.
- On Feb. 22, 2022, an employee used a high-pressure hose to clean a large spinner machine during manufacturing of RTE diced onions in the main production room, then contacted the floor with the hose, causing spray water to aerosolize and splash directly from the floor onto draining bins located approximately five feet away that contained RTE diced onions.
2. The firm did not maintain buildings, fixtures, and other physical facilities in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated, as required. Specifically, FDA investigators observed the following:
- On Feb. 8, 2022, condensate was observed dripping from the overhead ceiling and refrigeration unit in the main production room to the floor, approximately 10 feet from where RTE diced red onion was being processed.
- On Feb. 10, 2022, the plastic conveyer belt that they use for production of their butternut squash product was damaged, with rough surfaces and missing teeth.
- On Feb. 22, 2022, several areas of flooring and surfaces around drains in the main production area were damaged, with exposed rough aggregate.
- On Feb. 22, 2022, plastic bins/barrels used to hold RTE finished products, vegetable and fruit waste, and garbage were damaged, cracked, and chipped, with rough surfaces.
The full warning letter can be viewed here.
Kuzmir Imports Inc.
Hillburn, NY
An import company in New York is on notice from the FDA for not having FSVPs for a number of imported food products.
In an Aug. 2, 2022, warning letter the FDA described a March 10-23, 2022, Foreign Supplier Verification Program (FSVP) inspection of Kuzmir Imports Inc. in Hillburn, 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 483a. Some of the significant violations are as follows:
1. The firm did not conduct a hazard analysis for each type of food they import to determine whether there are any hazards requiring a control, as required. They may meet their requirement to determine whether there are any hazards requiring a control by reviewing and assessing the hazard analysis conducted by another entity using a qualified individual and documenting their review and assessment of that hazard analysis, including documenting that the hazard analysis was conducted by a qualified individual. During the inspection, they provided multiple documents related to their mini soup croutons onion garlic from foreign supplier (redacted) located in (redacted), nougat spread from foreign supplier (redacted) located in (redacted), and cashews from foreign supplier (redacted) located in (redacted), including specification sheets and process flow charts provided by their foreign suppliers.
2. The firm did not approve their foreign suppliers based on an evaluation of the foreign supplier’s performance and the risk posed by the food, and document their approval, as required. Specifically, for (redacted) located in (redacted), (redacted) located in (redacted), and (redacted) located in (redacted), they did not evaluate their foreign supplier’s performance and risk posed by the food or approve their suppliers based on this evaluation and document their approval.
3. The firm did not meet the requirements to perform foreign supplier verification activities in accordance with regulations for the products they import. Specifically, they did not document their determination or performance of appropriate supplier verification activities for mini soup croutons onion garlic from foreign supplier (redacted) located in (redacted); nougat spread from foreign supplier (redacted) located in (redacted); and cashews from foreign supplier (redacted) located in (redacted).
The full warning letter can be viewed here.
Bacocas Enterprises Inc.
Vernon, CA
An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products.
In a July 25, 2022, warning letter the FDA described an April 8, 2022, Foreign Supplier Verification Program (FSVP) inspection of Bacocas Enterprises Inc. in Vernon, CA.
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 significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP as required.
Specifically, they did not develop an FSVP for any of the food that they import, including each of the following food products imported from (redacted) located in (redacted):
- Watermelon
- Spaghetti squash
- Kabocha squash
The full warning letter can be viewed here.
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