Introduction

On July 22, 2019, the U.S. Food and Drug Administration (FDA) suspended the food facility registration of Topway Enterprises Inc.'s (Topway) Houston, Texas seafood processing facility. As a result, Topway cannot sell or distribute any food into commerce (the suspension). The suspension followed in the wake of several earlier inspections conducted by the FDA and the Texas Department of State Health Services (TDSHS) at Topway, which uncovered a number of serious food sanitation violations. This alert briefly outlines how the FDA regulates food, the events leading to the suspension, and some steps food producers can take to avoid suspensions and other sanctions by the FDA.

The FDA's Regulation of Food

The FDA regulates food under the Federal Food Drug and Cosmetic Act, or the FDCA, and other acts, including the Food Safety Modernization Act of 2011 (FSMA). The FSMA gives the FDA the ability to take a proactive role in regulatory oversight of foods, including but not limited to recall authority. The FDCA defines food broadly to mean "articles used for food or drink for man or other animals . . . and articles used for components of any such article." This definition allows the FDA to regulate across the broad food landscape. Foods are deemed to be adulterated if they contain any poisonous or deleterious added or naturally occurring substance "in a quantity that would ordinarily render [the food] injurious to health," if it contains any "filthy, putrid, or decomposed substance or if it is unfit for food," or if it has been "prepared, packed or held under insanitary conditions." (Emphasis added.)

Topway

Topway Enterprises produces and sells seafood products, including salmon and tuna, for raw consumption including in sushi. Topway's products include fish fillets packaged in a clear plastic wrap. The FDA, in its recent safety alert, was especially focused on Topway products distributed to restaurants in Texas and Louisiana from July 10 to July 13, 2019.

Topway Inspection History and Subsequent FDA Actions

On February 8, 2019, after a four-day inspection, the FDA issued a Form 483 to Topway. A Form 483 is issued to a company's management at the conclusion of an inspection when the FDA's investigator(s) have observed conditions that, in the investigator(s)' judgment, may constitute violations of the FDCA and related acts. The violations listed in the Form 483 to Topway described prepared and packed food being held under unsanitary conditions.

The Form 483 noted a number of violations, including unclean: processing room walls, cutting tables, plastic cutting surfaces, stainless-steel tables, knives, saws, coolers, ice machine residues, and paper towel dispensers—all of which were all observed to be contaminated with old fish processing residues. Also, the inspection team observed the floor of the production room and fish cooler to be in poor condition, with large cracks in the floor and uneven concrete that allows for water to pool in the room.

Standing water was observed "in the middle of the fresh fish cooler," a "pool of black water was observed in the middle of the fish cooler room," and "black residue" was found on the floor surface. The FDA observed that Topway could not assure "conformance with current Good Manufacturing Practices (cGMPs)," including "safety of water that comes into contact with food and food contact services." Further, in both its suspension press release and its advisory press release, the FDA notes that samples taken during different inspections confirmed the presence of different bacteria, including Listeria and pathogenic Listeria monocytogenes. Topway agreed to implement corrective actions in the wake of the FDA's inspection.

In June 2019, the TDSHS conducted a follow up inspection during which four "environmental samples tested positive for Listeria monocytogenes" and inspectors "observed continuing sanitation and seafood safety compliance issues." On July 3, 2019, after notification by the FDA and the TDSHS, Topway "agreed to voluntarily cease operations and recall products." On July 10, 2019, the FDA "became aware that Topway . . . resumed production at its facility without implementing adequate corrective actions to address the risks that were identified." On July 11, 2019, the FDA advised Topway to cease operations "until additional corrective action is performed, and no contamination can be detected at the facility." The FDA, however, was unable to confirm that consignees of the recalled food "were notified of the firm's recall and were able to take action to remove the existing product from the market." As a result, the FDA published the advisory press release on July 18, 2019 and the suspension press release on July 22, 2019.

The FDA's suspension of Topway's food facility registration is not the first time the agency has taken this type of aggressive enforcement against a food company, and this trend appears to be growing. Examples of similar food facility suspensions include:

• In October 2018, the FDA suspended the food facility registration of Working Cow Homemade, Inc.'s ice cream manufacturing facility located in St. Petersburg, Florida. The FDA inspections of the company's facility in 2017 and 2018 had identified unsanitary conditions. Subsequently, the company's ice cream products were linked to three cases of listeriosis in Florida.
• In March 2017, the FDA suspended the food facility registration of Dixie Dew Products, Inc., located in Erlanger, Kentucky, after an FDA inspection of the company's facility identified unsanitary conditions that could lead to contamination from E. coli. The FDA later determined that the company's soy nut butter product was implicated in an outbreak of E. coli.
• In September 2016, the FDA suspended the food facility registration of SM Fish Corp's seafood processing facility, located in Far Rockaway, New York, after a second FDA inspection of the company's facility over a period of several months uncovered Listeria monocytogenes contamination throughout the facility.

Conclusion

There are several important takeaways from the suspension of Topway and the events leading up to the suspension. First, food producers should proactively maintain sanitary conditions when preparing, packing, and holding food to avoid adulteration. Second, food preparation and packing should conform to food cGMPs at all times. Third, if the FDA or a state agency conducts an inspection and notes violations, food producers should address those violations in timely fashion. Fourth, when committing to the FDA or a state agency to take corrective actions, food producers should implement such corrections as quickly as possible.

For questions regarding FDA regulation of food, food preparation and food cGMPs, please contact Georgia Ravitz or any member of Wilson Sonsini's FDA Regulatory, Healthcare, and Consumer Products practice.