Fishy manufacturer shut down until it literally cleans up shop

An Alabama district court has permanently enjoined a seafood manufacturer from distributing adulterated and misbranded seafood products. The Department of Justice (DOJ), at the FDA’s request, filed a complaint alleging that BEK Catering LLC d/b/a Floppers Foods LLC and its owners caused food to be held under insanitary conditions. The injunction prevents the company and its owners from processing, packing, and holding fish or fishery products.

Inspection and complaint

In 2015, the FDA found that the company failed to control the risk of the growth of three different types of bacteria, and did not have adequate control over hazards that could be created by allergens and additives. The bacteria found during the inspection can cause foodborne illness, botulism, and listeriosis. The complaint noted that five different inspections beginning in 2011 revealed insanitary conditions and repeated regulatory violations.

Consent decree

The consent decree requires the company and its owners to cease operations beyond those incidental to product transport and delivery. In order to resume operations, they must notify the FDA 90 days in advance, comply with a set of remedial measures, and undergo inspection. The remedial measures include hiring an expert to ensure that operations conform with seafood hazard analysis critical control point (HACCP) and current good manufacturing practice (cGMP) regulations, all deficiencies are addressed, an employee training program is developed, and the FDA approves all changes.

Guilty plea, injunction for cheesemaker linked to listeriosis outbreak

Three years after its products sickened eight people in a Listeria monocytogenes (L. mono) outbreak, Roos Foods, Inc., a Delaware cheese manufacturer, pleaded guilty to a criminal misdemeanor count of violating the federal Food, Drug, and Cosmetic Act (FDC Act) by introducing adulterated food into interstate commerce. At the same time, Roos Foods and two of its owners entered into a consent decree of permanent injunction requiring them to cease receiving, preparing, processing, packing, holding and distributing all food products unless and until they bring operations into compliance with the FDC Act.

Roos Foods made ready-to-eat cheeses, including ricotta, queso fresco, and fresh cheese curd. In 2013, five adults and three newborns in Maryland and California had listeriosis—a serious, potentially fatal disease caused by L. mono—linked to Roos Foods’ cheese. The Department of Justice noted that L. mono is a “particularly significant public health risk” in ready-to-eat foods, because unlike many foodborne microbes, L. mono is capable of adapting and growing at refrigerator temperatures.

In March 2014, the FDA suspended Roos Foods’ food facility registration after linking the listeriosis outbreak to their cheese products and conducting facility inspections. The FDA’s inspection revealed significant sanitation deficiencies and found L. mono on 12 surfaces in the facility. Roos Foods has not reopened.