MONROE — In a 2021 inspection at Felix Custom Smoking, the Food and Drug Administration tested 104 surface samples in the seafood manufacturer’s facility in Monroe.
In 19 samples, inspectors found Listeria mono. The harmful bacteria had directly touched five food-contact surfaces and two used to process ready-to-eat seafood.
One year after filing a complaint to stop them from selling and distributing contaminated seafood, federal officials served a final judgment in March to Felix Custom Smoking, requiring the business to pay the costs of all further FDA investigations into the company — along with a 20-plus page list of requirements for the business to resume.
And if the FDA decides Felix Custom Smoking violates the permanant injunction filed in U.S. District Court, the agency has the power to it shut down.
It was unclear if the business was operational this week. A Daily Herald reporter called the business Friday, but the line had been disconnected.
The Monroe company manufactured ready-to-eat seafood products like smoked salmon and squid jerky for private companies in and outside Washington, but also served retail customers. The company processed seafood caught in Alaskan waters. Products were typically picked up at their facility.
Following the inspection in 2021, the FDA issued a public health advisory for a potential Listeria mono contamination.
FDA officials called owner Diane Zollinger at least five times about their concerns between August and October, court documents say. On these calls, Zollinger reportedly declined a voluntary recall of her products.
Federal officials filed a legal complaint against Zollinger in March 2022, claiming her company was “causing food to become adulterated.”
“The defendant has an extensive history of processing seafood products under grossly insanitary conditions,” the March 2022 complaint said.
Listeria mono, found in “various locations” throughout the Monroe facility, can grow in all vacuum-packed, ready-to-eat foods — but fish can be especially prone since the bacteria is often present in its raw form, according to the complaint.
“Over 40% of the salmon out of the ocean has listeria on it!” Zollinger said in a 2022 email to The Herald. “It’s my job to kill it.”
The bacteria cause the disease listeriosis, which is especially harmful to the immunocompromised and newborns. The most serious forms of listeriosis can result in meningitis and septicemia.
The business owner failed to appear in court, or to respond to the complaint in writing, documents say.
In April 2022, attorneys at the U.S. Department of Justice’s Consumer Protection Branch asked to give Zollinger more time to answer the summons. Zollinger was reportedly “undergoing medical treatment” and agreed to keep her business closed until after the deadline.
Due to Zollinger’s lack of response, U.S. District Court Judge Tana Lin issued a default judgement in favor of regulators on March 15.
The defendant is required to pay all costs of recalls and “other corrective actions” performed by the FDA, the documents say.
Under the order, the company must pay $102.39 an hour for investigative work and $122 for analytical work, court documents say.
The order requires Felix Custom to develop and provide the FDA a written Hazard Analysis and Critical Control Points plan for each manufactured fish product to limit future safety hazards. Specifically, the order requires the company to write a “Listeria Monitoring Program.”
Zollinger must notify employees and customers of the order. The document has to be posted near the front door to be visible, and the company must hold a general meeting with staff and provide a copy to employees. In 2022, Zollinger said her company had “2½ employees.”
If the company violates orders, Felix Custom must pay $2,000 for each violation.
Zollinger did not respond to a reporter’s requests for comment last week.
“I have been at this business for over 30 years,” Zollinger wrote in her email to The Herald in 2022. “We have had nothing but rave reviews from our customers and inspectors even to the point of an inspector coming back to me and asking how I did it.”
If Zollinger complies with the order for five years, she is eligible to petition for relief.
Maya Tizon; 425-339-3434; maya.tizon@heraldnet.com; Twitter: @mayatizon.
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