Caito’s response to earlier FDA inspection observations did not prevent Salmonella problem


This story by Phyllis Entis first appeared in Food Safety News and is reposted here with permission

On June 8, 2018, the federal Centers for Disease Control and Prevention advised the public of an outbreak of Salmonella Adelaide that eventually sickened 77 people in nine states.

Most of the outbreak victims reported eating pre-cut cantaloupe, watermelon or a fruit salad mix with melon purchased from grocery stores.

According to the CDC, epidemiologic and traceback evidence pointed to consumption of pre-cut melon supplied by Caito Foods LLC of Indianapolis.

In response to the evidence, the U.S. Food and Drug Administration (FDA) performed a three-week long investigation, including a comprehensive inspection of Caito’s production facility and analysis of several environmental and cut fruit samples.

FDA lab analysis did not reveal Salmonella in any of the samples taken during the course of the investigation. However, the Michigan Department of Agriculture and Rural Development (MDARD) found Salmonella Adelaide after testing samples of cut cantaloupe and watermelon.

Although FDA did not confirm the presence of Salmonella in Caito’s production facility during the inspection, investigators noted several sanitation and maintenance issues, according to the Establishment Inspection Report, obtained by Food Safety News as part of a Freedom of Information Act request.

  • The plant was not designed to facilitate maintenance and sanitary operations. There was condensation from the cooling units and on electric cords located directly above the pineapple line, where fresh, ready-to-eat pineapples were being peeled and cut.
  • The firm did not conduct operations under conditions and controls necessary to minimize the potential for contamination of food. Five employees were observed neglecting appropriate personal sanitizing procedures when entering the production area.
  • The firm did not take a reasonable measure and precaution related to personnel practices. Employees were seen handling containers and packing materials and then returning to cut watermelon without first cleaning and sanitizing their hands.
  • The cooling units’ fans appeared to be dirty.
  • The firm used a lower concentration of sanitizing chemical than called for on the package label. Management explained that the sanitizer was used to ensure the safety of the water, and not to provide a sanitizing step for the fruit.

During the current inspection the firm on June 14, 2018, Caito Foods LLC voluntary destroyed all the melons and watermelons that they had in their warehouse and diverted any shipments that they had coming. The firm also destroyed any products containing melon or watermelon.

FDA never found the source of the Salmonella Adelaide contamination.

In its official response to FDA’s observations, Caito management detailed corrective actions intended to eliminate the condensation problem and prevent a recurrence. The company developed a new procedure regarding management, sanitation, and handling of all food contact containers, and completed a retraining program for employees on handling procedures and hand sanitizing requirements.

Caito also adjusted the concentration of sanitizing chemical.

Despite its corrective actions, Caito is once again the apparent source of a Salmonella outbreak. As of April 24, CDC had received confirmed reports of 117 cases of Salmonella Carrau infections in 10 states. Thirty-two people have been admitted to hospitals.

Epidemiologic and traceback evidence has identified Caito as the likely source of the outbreak.

According to FDA, Salmonella Carrau is rare, and has historically been seen in imported melons. Caito has acknowledged that imported melons were used in the suspect pre-cut melon mixes.

FDA is examining shipping records to establish a country of origin and, if possible, a farm of origin for the melons.

Caito recalled all of the implicated pre-cut melons and fruit mixes containing pre-cut melons on April 12.

Public health officials from CDC and FDA advise consumers to check their homes for recalled products and either throw them away or return them to the place of purchase. Consumers who believe they have become ill as a result of consuming pre-cut melon should consult their healthcare provider.

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