FDA closes SM Fish; Listeria at facility matches sick people

Federal officials have effectively closed down a New York company after repeatedly finding Listeria in its food production plant, reporting that one of the seven strains of the pathogen in the facility genetically matches infections in at least four people.

The Food and Drug Administration has suspended the food facility registration of SM Fish Corp. of Far Rockaway, NY. The agency had been working with the company to determine the source of Listeria monocytogenes that triggered recalls of Ossie’s brand ready-to-eat products on July 29 and Sept. 15.

Since April this year, FDA staff has collected environmental samples at the production plant during three separate inspections. Lab tests showed at least seven different strains of Listeria monocytogenes from 56 of those samples.

The FDA used whole genome sequencing to match one of those strains to Listeria monocytogenes isolates from four people infected with listeriosis, according to a Sept. 13 letter sent to SM Fish Corp. president Robert J. Schonfeld.

The agency did not provide details about when the four people were sickened or where they live.

“While this order is in effect, pursuant to section 415(b)(4) of the FD&C Act, no person can import or export food into the United States from your facility, offer to import or export food into the United States from your facility, or otherwise introduce food from your facility into interstate or intrastate commerce in the United States,” the letter states.

The problems at the SM Fish Corp. facility did not begin this year, however. The FDA found three strains of Listeria monocytogenes in the production facility repeatedly during a two-year period.

“The multiple findings of (Listeria) monocytogenes throughout your processing facility are significant because it indicates widespread and persistent harborage of L. monocytogenes contamination. The most recent finding of L. monocytogenes on a direct food contact surface is of particular concern,” according to the letter to SM Fish Corp.

“Further, the presence of L. monocytogenes at a significant rate in a wet processing environment with a high amount of manual packing is likely to lead to cross contamination and transmission of the pathogen to the finished RTE product. FDA’s environmental findings further support that your firm’s sanitation practices are ineffective and that your firm lacks an understanding of how to control or eliminate L. monocytogenes.”

Warning to consumers
In its suspension safety alert, FDA warns consumers to check their homes for any ready-to-eat products from SM Fish Corp. — including Ossie’s brand fish and egg salads. Consumers should not eat the products.

Those who have eaten the products should monitor themselves for symptoms of Listeria infection, which can take up to 70 days to develop after eating contaminated food.

“Anyone who has experienced fever and muscle aches, sometimes preceded by diarrhea or other gastrointestinal symptoms, or developed fever and chills while pregnant, after having eaten any recalled SM Fish products should seek medical care,” according to the FDA alert.

“Listeriosis can be fatal, especially in certain high-risk groups. These groups include the elderly, and people with weakened immune systems and certain chronic medical conditions, such as cancer. In pregnant women, listeriosis can cause miscarriage, stillbirth, premature labor, and serious illness or death in newborn babies.”

Consumers who handled recalled product should follow these simple steps:

• Wash the inside walls and shelves of the refrigerator, cutting boards and countertops; then sanitize them with a solution of one tablespoon of chlorine bleach to one gallon of hot water; then dry with a clean cloth or paper towel.
• Always wash hands with warm water and soap following the cleaning and sanitization process.

Score one for SCORE
The discovery of the “widespread and persistent harborage” of Listeria monocytogenes at the SM Fish Corp. production facility is being logged in the win column of FDA’s recently established Strategic Coordinated Outbreak Response and Evaluation (SCORE) decision-making body.

The group, created in April this year, includes key senior leaders who requested additional sampling of the SM Fish facility. The request came after an inspection — June 14 to July 6 — resulted in 29 of 105 environmental samples testing positive for Listeria.

“Some of these samples were adjacent to food contact surfaces,” according to FDA’s announcement.

The company briefly ceased operations at FDA’s request to revise its cleaning and sanitation procedures.

When FDA re-inspected and re-sampled the SM Fish facility — Aug. 15 to Sept. 9 — testing results showed that Listeria was detected in 12 out of 116 locations, including on a direct food contact surface.

“FDA will vacate the Suspension of Food Facility Registration Order and reinstate SM Fish’s food facility registration only when the agency determines that food from its facility no longer has a reasonable probability of causing serious adverse health consequences or death to humans,” according to the agency’s announcement.

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from Food Recalls – Food Safety News http://ift.tt/2cnK89O