This means no food may leave the facility of Dixie Dew Products, Inc. (Dixie Dew) of Erlanger, Kentucky for sale or distribution.
However, FDA said it did not have evidence that other products made in the facility are contaminated but it is collecting and testing them.
Dixie Dew made I.M. Healthy brand SoyNut Butter which is behind an outbreak that has sickened 29 people in 12 states.
Arizona, California, Florida, Illinois, Massachusetts, Maryland, Missouri, New Jersey, Oregon, Virginia, Washington and Wisconsin have reported cases.
Twelve people have been hospitalized and nine developed hemolytic uremic syndrome (HUS), a type of kidney failure.
A total of 83% are younger than 18 years, said the Centers for Disease Control and Prevention (CDC).
Illness dates range from January 4 to March 13. It takes an average of two to three weeks between when a person becomes ill and when the illness is reported.
FDA flexes muscles after refusal
An inspection identified unsanitary conditions that could lead to contamination with E. coli O157:H7 in finished products, said the FDA.
In early March, Dixie Dew refused FDA investigators access to environmental sampling and production records.
The FDA made a Demand for Records under the Federal Food, Drug, and Cosmetic Act and then the firm provided investigators with the necessary items.
These powers are available under the Food Safety Modernization Act.
FDA gave Dixie Dew a list of investigators’ observations.
“Your facility's cleaning SOP mentioned having cleaning logs for all processing equipment, floors and walls, the lab, office, break room, and restrooms; however, no cleaning logs were being kept at the time of the inspection and in fact had not been maintained in several years,” said the agency.
Dixie Dew responded with actions it has taken to correct the conditions; however, FDA found these were not adequate to fully address the risks and suspended the food facility registration to prevent further illnesses.
“These corrective actions include repair of the leak in the ceiling tile, labeling forklifts on where they may be used and promising to clean them, installing a new hot water heater and soap dispenser for the hand washing sinks, retraining employees on hand washing, and repairing the floor, cooler and ceiling tiles.
“Although you indicated that Dixie Dew disassembled and cleaned its equipment, you did not state that the equipment had been sanitized. Indeed, the standard operating procedure you submitted lacked details on the detergents and sanitizing chemicals to be used, what is to be cleaned and sanitized, and what equipment will be disassembled prior to cleaning and sanitizing.
“You also did not describe any means of verifying the effectiveness of the cleaning and sanitization procedures other than visual inspection, which is not adequate for pathogen control.”
Positive testing and recalls
The outbreak strains have been found in I.M. Healthy brand SoyNut Butter from the homes of ill people and retail locations.
Six samples collected by the California Department of Public Health and one each by the Oregon Health Authority and Washington Department of Health tested positive and matched the outbreak strains by PFGE.
The SoyNut Butter Company has recalled all varieties of I.M. Healthy SoyNut Butters and I.M. Healthy Granola products.
The firm expanded the recall to include Dixie Diner’s Club brand Carb Not Beanit Butter.
Pro Sports Club in Washington (Bellevue, Redmond and Seattle) recalled Yogurt Peanut Crunch bars as they use the soy nut butter as an ingredient.
Twenty-one of the 28 people interviewed either ate I.M. Healthy brand SoyNut Butter at home (15 people) in the week before they became ill, attending a facility that served it (two), or attending childcare centers that served it and I.M. Healthy brand granola coated with SoyNut Butter (four).