FDA uses its power to suspend food facility registration for sixth time

Topway Enterprises Inc, doing business as Kazy’s Gourmet in Houston, has lost the federal registration required to sell or distribute food.

The U.S. Food and Drug Administration Tuesday announced it suspended Topway’s food facility registration. The federal agency took action after FDA, and the Texas Department of State Health Services discovered Listeria and pathogenic Listeria monocytogenes (L. monocytogenes) inside the Topway facility.

It is the sixth time the FDA has suspended a facility’s registration since the agency received that authority under the 2011 Food Safety Modernization Act.

FDA delivered a safety alert to Topway on July 18, but it did not result in any corrective actions by the facility.

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. No illnesses are yet associated with Topway products.

“The FDA and the Texas DSHS have documented a pattern of food safety violations at the Topway facility, said FDA Deputy Commissioner for Food Policy and Response Frank Yiannas. “As well as an unwillingness and disregard by the company to cease operations and correct severe violations.”

Yiannas says Topway’s unsafe practices violate the law. It continues to ship products for public consumption with Listeria contamination knowingly.

Restaurants and retailers should step selling Topway’s ready-to-eat seafood, according to the safety alert. Seafood consumers in Texas and Louisana who purchased salmon and tuna for raw consumption are urged to check with their suppliers about its origin and processing.

Discard any Topway seafood shipped to restaurants and retailers, advises the safety alert.

L. monocytogenes is 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.

Afterward, the agency left Topway with the FDA Form 483 for inspectional observations. It documented unsanitary conditions.
Problems included:

• poor employee sanitation and production practices
• significant facility deficiencies
• 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.

When initially presented with the inspection observations, Topway promised to take corrective action, according to the FDA.

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 cease operations and recall certain products voluntarily.

To date, the company has not implemented adequate corrective actions to address the identified risks. 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 a 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.

Consumers who 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.

FDA is a U.S. Department of Health and Human Services (HHS) agency. FDA is responsible for the safety and security of the nation’s food supply.

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