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FDA News Release

FDA suspends facility registration of Texas-based seafood producer after significant, repeated food safety violations

For Immediate Release:

The U.S. Food and Drug Administration today announced it has recently suspended the food facility registration of Topway Enterprises Inc., also doing business as Kazy’s Gourmet, of Houston, Texas. Topway now cannot sell or distribute any food into commerce. This action follows inspections conducted by the FDA and Texas Department of State Health Services (DSHS) earlier this year where serious sanitation issues were observed, including several samples confirming the presence of Listeria and pathogenic Listeria monocytogenes (L. monocytogenes).

The company has yet to implement adequate corrective actions at their facility and as a result the FDA-issued safety alert on July 18. The alert advises restaurants and food retailers in Texas and Louisiana to stop selling and discard recent shipments of Topway’s ready to eat (RTE) seafood products, including raw tuna and salmon, due to possible Listeria contamination. This is the sixth time the FDA has suspended a facility’s registration since receiving the authority under the FDA Food Safety Modernization Act.

“The FDA and the Texas DSHS have documented a pattern of food safety violations at the Topway facility as well as an unwillingness and disregard by the company to cease operations and correct severe violations at their facility. Topway’s unsafe practices not only violated the law, but also jeopardized the health of consumers as the company continued to knowingly distribute food products likely to be contaminated with Listeria for public consumption,” said FDA Deputy Commissioner for Food Policy and Response Frank Yiannas.

In addition to advising restaurants and food retailers to stop selling Topway’s RTE seafood products, the FDA safety alert specifically advises consumers who have recently purchased RTE seafood products in Texas and Louisiana, particularly salmon and tuna for raw consumption, to contact the restaurant or food retailer for more information about where the seafood was processed and sourced. Topway ships RTE fresh seafood products to restaurants and food retail outlets. Consumers who think they have purchased or consumed Topway products should discard products.

L. monocytogenes a species of disease-causing bacteria. When people eat food contaminated with L. monocytogenes, they may develop a disease called listeriosis. This infection can have serious adverse effects for consumers, particularly women who are or may become pregnant, the elderly, and people with weakened immune systems. Therefore, the FDA continues to advise that recipients of Topway RTE seafood products, clean and sanitize the surfaces on which these products were served, stored or prepared.

The FDA first inspected the Topway facility in February, which resulted in the detection of 31 non-pathogenic Listeria on swabs collected throughout the facility and observations of egregious sanitation deficiencies. At the close of the inspection, the investigators issued a FDA Form 483 to document inspectional observations pertaining to insanitary conditions at the facility. The form noted poor employee sanitation and production practices and significant facility deficiencies, such as cracked and uncleanable floors in the high-traffic areas such as the production and fish cooler rooms, pools of black water on the fish cooler floors, uncleaned utensils used to process seafood, fish particles on production room walls, and an accumulation of residues on seafood processing tables. The FDA alerted Topway of the agency’s findings and the company assured the agency it would take corrective actions.

On behalf of the FDA, the Texas DSHS conducted a follow-up compliance inspection from June 24 through July 3. State inspectors observed that the company had not corrected the sanitation and seafood safety compliance deficiencies identified by the related FDA inspection. This inspection resulted in 66 non-pathogenic Listeria positive samples, egregious sanitation deficiency observations and four environmental swabs that tested positive for L. monocytogenes.

On July 3, FDA and Texas officials notified Topway of the recent environmental sampling results for their facility. The company agreed to voluntarily cease operations and recall certain products. To date, the company has not implemented adequate corrective actions to address the risks that were identified. Topway also continued production by operating in a temporary location where it moved some equipment and personnel to process seafood products for sale while performing cleaning at its facility.

The FDA is in the process of working with the company to address the violations at both locations. Only after an appropriate corrective plan has been established and implemented at both the facility and temporary processing location will the FDA consider allowing the company to resume operations.

The FDA is not aware of any confirmed illnesses related to these seafood products. However, consumers who think they may have been sickened by these products should seek the assistance of a health care professional and contact the FDA to report problems with any FDA-regulated products.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.



Peter Cassell

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