Listeria contamination in facilities and on products triggers FDA warnings

As part of its enforcement activities, the Food and Drug Administration issues warning letters to entities under its jurisdiction. Some letters are not displayed to the public until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters are often not issued until a company has had months or even years to correct the issues. The FDA frequently redacts portions of warning letters posted to the public.

Fresh cut from Onofrio Inc.
New Haven, Connecticut

A Connecticut food company is warned by the FDA of serious violations after inspectors found Listeria in the company’s production facility.

In a January 10, 2022 warning letter, the FDA described July 13-29, 2021 inspections at Onofrio’s Fresh Cut Inc. in New Haven, CT.

The FDA inspection revealed that the company was not in compliance with FDA regulations and resulted in the issuance of an FDA Form 483.

Some of the cited violations:

Violations of risk analysis and risk-based preventive controls:

  1. The company did not properly assess contamination from environmental pathogens, such as Listeria monocytogenesto determine if it is a hazard requiring preventive control in its fresh-cut products.

The FDA inspection included the collection of environmental swabs on July 13, 2021, during production of ready-to-eat (RTE) fruits and vegetables. Four of the 71 swabs were confirmed positive for Listeria monocytogenes. Positive results included a mixing room floor drain adjacent to a table where RTE celery was cut, forklift wheels, a wheel on a rolling cart containing shrimp and seafood salad ingredients, and a packing room broomstick.

The recurring presence of Listeria monocytogenes at their facility is significant in that it demonstrates that their sanitation procedures were inadequate to significantly minimize or prevent Listeria monocytogenes in the building.

  1. The company has not identified and implemented appropriate preventive control to ensure that any hazards requiring preventive control will be significantly reduced or avoided and that food manufactured, processed, packaged or stored by its establishment will not be adulterated.

Specifically, they have not established supply chain controls for pathogens such as Listeria monocytogenespathogenic E.coliand Salmonella at the receiving stage of incoming products.

Current Good Manufacturing Practices:

  1. The company’s plant has not been constructed in such a way that drips or condensate from fixtures, ducts and pipes will not contaminate food or food contact surfaces. Specifically, on July 14, 2021, FDA investigators observed the following conditions:
  • Condensate droplets on the underside of the refrigeration unit above a blue bin containing RTE baby carrots and above the (redacted) conveyor in the vegetable laundry.
  • Condensation droplets on the ceiling throughout the vegetable mixing room directly above uncovered RTE vegetables, including peppers, onions and zucchini, and above food contact surfaces.
  1. The company’s factory lacked adequate sanitary facilities and housing, as the plumbing was not properly installed and maintained to avoid being a source of contamination to food, water supply, equipment or utensils or create an unsanitary condition. Concretely, on July 13, 2021, the hand washing sink located at the end of the (redacted) conveyor in the vegetable washing room leaked a large amount of water onto the floor while in use. Also, on July 14, 2021, a small amount of water was leaking under the same hand washing sink (near the pedals) onto the floor. The firm explained that the sink leak was due to a clogged drain.
  2. The company has not cleaned and sanitized its utensils and equipment in a manner that protects against contamination of food contact surfaces. Specifically, on July 15, 2021, during the pre-operational inspection, the cutting board in the vegetable cutting room failed inspection and was cleaned again. During the re-cleaning, an employee was observed placing a bucket containing a soapy solution, which had previously been on the floor of the production room, on the cutting board during the washing stage. In addition, the same employee placed the spray nozzle of the water pipe that had previously been on the floor of the production hall on the discharge side of the (redacted) conveyor.
  3. The company was not cleaning non-food contact surfaces of equipment in a manner and as frequently as necessary to protect against food contamination. Specifically, on July 14, 2021, an employee was observed rinsing the floor and cutting boards with a water hose in the mixing room. Hose overspray was near two trays partially covered with MAP cut celery.
  4. The company has not taken adequate precautions to ensure that production procedures do not contribute to contamination. Specifically, on July 13, 2021, while employees were processing RTE onions in the (redacted) room, the (redacted) The line was stretched across the floor of the production hall, then draped over a bin containing RTE processed onions.

The full warning letter can be viewed here.

Concord Farms Inc.
Vernon, California

An import company in California is notified by the FDA after an inspection was initiated by a recall. The recall was due to Listeria monocytogenes was found on their fresh enoki mushrooms.

In a January 6 warning letter, the FDA described a Foreign Supplier Verification Program (FSVP) inspection from July 20 to August 3, 2021 of Concord Farms Inc. in Vernon, California.

The FDA inspection revealed that the company was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a.

The firm’s material breaches of the FSVP Rules are as follows:

  1. The company has not developed, maintained and tracked an FSVP. Specifically, they have not developed an FSVP for each of the following foods they import:
  • Ginger root imported from (redacted)
  • Pear imported from (redacted)
  • Ginger root imported from (redacted)
  • bamboo shoots (redacted)
  • Ginger root imported from (redacted)
  • Ginger root imported from (redacted)
  1. The company must conduct a written hazard analysis for each type of food it imports to determine if there are any hazards that need to be controlled. However, they have not provided the FDA with any documentation that they have reviewed and assessed their foreign supplier’s risk analysis.
  2. The company must approve its foreign suppliers based on an assessment of the performance of their foreign suppliers and the food risk posed to the products they import. When approving its foreign suppliers and determining appropriate supplier verification activities, the company did not consider foreign suppliers’ food safety procedures, processes and practices. Additionally, the company’s assessment did not take into account applicable FDA food safety regulations or information about foreign suppliers’ compliance with these regulations. Specifically, the company’s enoki mushrooms imported from (redacted)shipped by (redacted)their enoki mushrooms imported from (redacted)and their oyster mushrooms imported from (redacted)are raw agricultural commodities, however, their supplier evaluation and approval records dated July 8, 2021 did not demonstrate consideration of supplier compliance with the Commodity Safety Rule requirements.
  3. The company’s supplier verification activities have not provided sufficient assurance that hazards requiring control in the foods they import have been significantly minimized or prevented.

Specifically, the “FSVP Foreign Supplier Verification Activity Worksheets” dated July 8, 2021, for enoki mushrooms imported from (redacted)shipped by (redacted)enoki mushrooms imported from (redacted)and oyster mushrooms (redacted), describe their verification activities as “review of safety records” and the rationale for their verification activities as “SAHCODHA Haz (annual sight audit)”. The records they have provided to demonstrate their verification activities for these foods and suppliers include GlobalGAP certificates, HACCP system certificates, certificate for “pesticide free crops” and heavy metal test results in the water. However, these records do not indicate whether they have verified their suppliers’ compliance with the product safety rule and do not compare the standards on which the certificates are based to the level of public health protection provided by the product safety rule. product safety.

  1. The company must ensure that, for each line of food product entry offered for import into the United States, the name, email address, and unique identifier of the establishment recognized as acceptable by the FDA, identifying it as the importer of the food, are provided electronically when filing a declaration with US Customs and Border Protection. However, the required information was not provided to identify them as the FSVP importer for several shipments of mushrooms they imported.

The full warning letter can be viewed here.

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