July 18, 2019

Audience

• Restaurants and food retailers that have received shipments of Topway Enterprises Inc. or Kazy’s Gourmet ready-to-eat (RTE) seafood products, particularly salmon and tuna for raw consumption.
• Consumers, especially women who are or could become pregnant, the elderly, and persons with weakened immune systems who have recently consumed raw seafood products, particularly raw salmon and tuna in Texas (TX) and Louisiana (LA) and suspect they have food poisoning should seek medical care immediately.

Product

• Product: Topway Enterprise Inc. and Kazy’s Gourmet RTE seafood products, including tuna and salmon for raw consumption, received from July 10 to July 13, 2019. These seafood products may be incorporated into sushi.
• Packaging: Fillet wrapped in clear plastic wrap
• Distribution Information: These RTE seafood products, including raw tuna or salmon, were distributed to restaurants in TX and LA from July 10 to July 13, 2019. These products are typically sold fresh and do not have a long shelf life, though they can be frozen to extend the shelf life.

Purpose

Restaurants and food retailers should stop selling and discard recent shipments of Topway Enterprise Inc. (also doing business as Kazy’s Gourmet) RTE seafood products due to possible Listeria monocytogenes (L. monocytogenes) contamination.L. monocytogenesis a species of disease-causing bacteria. When people eat food contaminated with L. monocytogenes, they may develop a disease called listeriosis. A listeriosis infection can have serious adverse effects for women who are or may become pregnant, the elderly, and persons with weakened immune systems.

Topway Enterprises Inc. ships RTE seafood products to restaurants and food retail outlets, primarily in the states of TX and LA. The firm has indicated restaurants and food retailers received cut tuna and salmon from July 10 to July 13, 2019.

The FDA advises restaurants and food retailers that have received Topway Enterprise Inc. RTE seafood products to clean and sanitize the surfaces that these products were served, stored, or prepared on.

Summary of Problem and Scope

The FDA conducted a routine facility inspection of Topway Enterprises Inc. in February 2019. During the inspection, the FDA collected 53 environmental samples, 31 of which tested positive for non-disease-causing Listeria species and provided the firm with inspectional observations (Form FDA 483), noting serious sanitation issues. The FDA informed the company of the agency’s concerns and the company promised some corrective actions.

In June 2019, the Texas Department of State Health Services (DSHS) conducted a state contract inspection as a follow-up to FDA’s February 2019 facility inspection to evaluate whether the firm had implemented the corrective actions Topway Enterprises Inc. committed to following the February 2019 inspection and to test for possible foodborne illness-causing pathogens. During the DSHS inspection, four of the environmental samples tested positive for L. monocytogenes, and state inspectors observed continuing sanitation and seafood safety compliance issues as Topway Enterprises Inc. had yet to completely implement the corrective actions the firm had agreed to in February 2019. The FDA was notified of these findings on July 3, 2019 by the state.  

On July 3, 2019, the FDA and state partners notified the firm of the recent environmental sampling results. Topway Enterprises Inc. agreed to voluntarily cease operations and recall products. They also agreed to provide the FDA with any corrective action planned, prior to resuming operations. However, on July 10, 2019, the FDA became aware that Topway Enterprises Inc. resumed production at its facility, without implementing adequate corrective actions to address the risks that were identified.

FDA Actions

On July 11, 2019, in discussions with the company owner, the FDA advised that the company cease operations until additional corrective action is performed, and no contamination can be detected at the facility. Although the firm committed to recalling ready-to-eat seafood products, including tuna and salmon for raw consumption, FDA has been unable to confirm whether consignees of the recalled food were notified of the firm’s recall and were able to take action to remove existing product from the market. As a result, FDA is publishing this Safety Alert to notify businesses who may have received product from Topway Enterprises Inc. from July 10 to July 13, 2019.

Recommendations for Restaurants and Retailers

Restaurants and retailers that have received product from Topway Enterprises Inc. between July 10, 2019 and July 13, 2019 should discard the product and take appropriate action to ensure customers are not served the potentially contaminated food.

Food service operators who have handled potentially contaminated food in their facilities should:

• Wash the inside walls and shelves of the refrigerator, cutting boards and countertops, and utensils that may have contacted contaminated foods; then sanitize them with a solution of one tablespoon of chlorine bleach to one gallon of hot water; dry with a clean cloth or paper towel that has not been previously used.
• Wash and sanitize display cases and surfaces used to potentially store, serve, or prepare potentially contaminated foods.
• To prevent the growth of L. monocytogenes, set the refrigerator to 40 degrees Fahrenheit (4 degrees Celsius), and set the freezer to 0 degrees Fahrenheit (-18 degrees Celsius).
• Wash hands with warm water and soap following the cleaning and sanitation process. 
• Conduct regular frequent cleaning and sanitizing of cutting boards and utensils used in processing to help minimize the likelihood of cross-contamination. 

Unlike most bacteria, L. monocytogenes can grow at refrigeration temperatures and freezing will not eliminate or reduce the pathogen. The FDA recommends that retailers implement time and temperature controls to reduce the opportunity for the growth of L. monocytogenes.  L. monocytogenes can also cross-contaminate other food that has been cut and served on the same cutting board or stored in the same area. Retailers should check with your state for specific guidance. More information can be found in the FDA Food Code 2017.

Recommendations for Consumers

Consumers who have recently purchased raw ready-to-eat (RTE) seafood products, particularly salmon and tuna for raw consumption, in TX and LA should contact the restaurant or food retailer for more information about where the seafood was processed and sourced. Consumers who suspect they have had contaminated food in their homes should throw the food away and follow these steps:

• Wash the inside walls and shelves of the refrigerator, cutting boards and countertops, and utensils that may have contacted contaminated foods; then sanitize them with a solution of one tablespoon of chlorine bleach to one gallon of hot water; dry with a clean cloth or paper towel that has not been previously used. 
• Wipe up spills in the refrigerator immediately and clean the refrigerator regularly.
• Wash hands with warm water and soap for at least 20 seconds before and after handling food and following any cleaning and sanitation process.
• Pregnant women, the elderly and those with weakened immune systems should avoid certain foods, including raw fish and other raw foods, which carry a high risk for L. monocytogenes.

To report a complaint or adverse event (illness or serious allergic reaction), you can

• Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.
• Complete an electronic Voluntary MedWatch form online.
• Complete a paper Voluntary MedWatch form that can be mailed to FDA.

Visit www.fda.gov/fcic for additional consumer and industry assistance.

Additional Information:

• Listeria
• Food Safety for Moms to Be
• Preventing Listeria Infections