Monday, September 19, 2016
No food from the facility may be sold or distributed, Ossie's and Ossie's Gourmet ready-to-eat seafood products recalled
FDA is using authorities granted under the 2011 FDA Food Safety Modernization Act to suspend the food facility registration of SM Fish Corp. of Far Rockaway, NY, because food, including ready-to-eat (RTE) food, from this facility may be contaminated with L. monocytogenes (Listeria).
Consumers with any un-expired RTE food products manufactured by SM Fish should not eat these products, which were sold at the company's seven retail outlets located in New York and New Jersey, and instead throw these products away. This is an expansion from the July 29, 2016 recall to include all un-expired RTE foods from SM Fish.
Consumers should be aware that symptoms of listeriosis can appear from a few days up to a few weeks after consumption of contaminated food.
FDA's decision to suspend the registration of SM Fish was prompted by a second 2016 inspection showing widespread and persistent Listeria contamination throughout its food facility.
No food from SM Fish's facility may be sold or distributed while the food facility registration is suspended.
What is the problem and what is being done about it?
FDA issued a Suspension of Food Facility Registration Order to SM Fish Corp. of Far Rockaway, NY, after the agency's newly-established Strategic Coordinated Outbreak Response and Evaluation (SCORE) decision-making body of key senior leaders requested additional sampling of the SM Fish facility and results showed widespread and persistent Listeria contamination. SCORE was created in April 2016 to ensure the agency engages in an integrated approach to identifying timely and efficient measures in order to help mitigate public health risks. Today, this decision-making body evaluates the complexities and considers a wide range of options for use of compliance and enforcement authorities as early in the process as possible.
SCORE requested a re-inspection of the SM Fish facility after a June 14, 2016 to July 6, 2016 inspection resulted in 29 of 105 environmental samples testing positive for Listeria. Some of these samples were adjacent to food contact surfaces. As a result of the inspection, FDA recommended that SM Fish recall certain ready-to-eat food products, which the company did on July 29. The company also briefly ceased operations at FDA's request to revise its cleaning and sanitation procedures. The agency had inspected the firm in 2015 and found Listeria in 15 out of the 105 locations swabbed throughout the facility. FDA investigators issued a 483 inspection report outlining safety concerns and discussed with SM Fish actions it should take to reduce the prevalence of Listeria in its facility.
FDA re-inspected and re-sampled the SM Fish facility from August 15, 2016 to September 9, 2016 and learned that the firm's cleaning and sanitation procedures were unsuccessful in solving its environmental Listeria contamination. Testing results showed that Listeria was detected in 12 out of the 116 locations swabbed throughout the facility, including on a direct food contact surface. Other locations found to harbor the bacteria were non-food contact surfaces that are in sufficient proximity to the food and food contact surfaces to create an increased risk of contaminating the food, particularly considering inspection observations. Whole genome sequencing matched some of the Listeria findings genetically to samples collected during the June/July 2016 inspection, as well as to samples collected during the 2015 inspection, indicating that at least three strains of Listeria have been consistently present in this facility during a two-year period.
Following the re-inspection and additional Listeria findings, FDA used authority granted under the 2011 Food Safety Modernization Act to suspend the food facility registration of SM Fish on September 14, 2016. SM Fish may not sell or distribute any food from SM Fish's facility while its registration is suspended. The agency also recommended that SM Fish expand its July 29 recall to include all RTE foods within expiry, and the company issued the recall on September 15, 2016.
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.
What are the symptoms of listeriosis?
Listeriosis is a rare but serious illness usually caused by eating food contaminated with the bacteria called Listeria monocytogenes. 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. Consumers should understand that symptoms can appear from a few days up to a few weeks after consumption of the contaminated food.
Who is at risk?
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.
FDA advises consumers with any ready-to-eat fish products manufactured by SM Fish at this facility to not eat these products and instead throw them away. These products were sold at the firm's retail outlets located in New York and New Jersey. This is an expansion from the July 29, 2016 recall.
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.
If you are unsure of your risk, ask your healthcare provider.
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