April 19, 2024

FDA Inspectors Found Listeria, Food Safety Violations at Wholesome Soy

The investigation of the deadly bean sprout Listeria outbreak began with a routine inspection by the U.S. Food and Drug Administration (FDA). The outbreak, which began last summer was, was linked to bean sprouts from Wholesome Soy in Chicago. Five people in Michigan and Illinois were sickened. Two of them died.

Bean SproutsOn August 12, the FDA went to Wholesome Soy’s Chicago facility for a routine inspection that would last through September 3, 2014. They found Listeria in sprouts  and in irrigation water. After whole genome sequencing tests revealed that the Listeria strains found at Wholesome Soy were highly related to the strain isolated from five people who became ill, FDA investigators returned to the plant.

According to an inspection report, they found again found food safety violations and Listeria in sprout samples and in the facility. In all, they made 12 observations. They were:

Listeria monocytogenes was detected in the raw ready-to-eat sprout processing environment and in the peripheral warehouse area.

Employee practices allow for potential contamination. For example, bags of sprouts are packaged while they are directly on the wet sprout production area floor.

Equipment and utensils not properly maintained. For example, wooden pallets used to hold ready-to-eat finished sprouts are jagged and splintered.

Cleaning practices are not adequate. For example, the walls in the sprout growing rooms had “an apparent mold-like growth present.”

The sprout production area was not properly maintained. For example, the floor in the sprout production is cracked.

Lack of effective pest control procedures. For example, flying insects were present r in the sprout production area.

All reasonable precautions were not taken to ensure that production procedures didn’t contribute contamination. For example, an employee removing the tofu  from the cooling water submerged his or her arm and t-shirt sleeve.

The construction of the plant made it difficult to keep clean and  in good repair.
For example, the floor in the tofu area is cracked.

Employees did not use proper measures to clean and sanitize their hands. For example, they would handle non-food contact surfaces such as valves,hoses, cart handles and plastic bins and then come into direct contact with food products.

Effective measures were not taken to exclude pests from the processing areas and protect against the contamination of food. For example, insects were observed directly on food contact and non-food contact surfaces.

Failure to maintain equipment and utensils in acceptable condition through appropriate cleaning and sanitizing. For example, food contact surfaces in the tofu production area had chipped paint,  rust and food residue.

Instruments used to measure conditions that control or prevent bacterial growth were not adequately maintained. For example, thermometers were not calibrated.

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