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.


Caito Foods sanitation problems extend back to at least 2016

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

The Food and Drug Administration found multiple sanitation issues during a 2016 inspection of the Caito Foods fresh produce facility that prepared pre-cut melon products currently implicated in a Salmonella outbreak.

According to the Indianapolis company’s website, Caito specializes in fresh produce distribution and fresh food processing, selling to customers nationwide.

The September 2016 FDA inspection was undertaken following detection of Listeria monocytogenes in a sample of cut butternut squash by the Ohio Department of Agriculture (ODA), according to documents obtained from FDA in response to a Freedom of Information Act request.

The company decided not to recall the squash from the sampled lot, because the product was intended to be cooked by the consumer. Also, the company did not learn about the contamination until Sept. 9, 2016, which was five days after the “BEST IF SOLD BY” date for the batch.

FDA investigators spent two days on a “directed inspection” in response to the Listeria monocytogenes finding. Their inspection focussed on the processing of raw fruits and vegetables, including butternut squash.

The “Establishment Inspection Report” noted several observations, which were provided to management at the completion of the inspection.

  • Condensate dripping onto uncovered asparagus spears on the over-wrap line during the, even though the pre-operation sanitation checklist indicated “No condensation” for that date.
  • Pre-operation sanitation check list for the date during which the butternut squash sample was produced identified three locations as “unsatisfactory” with no corrective actions indicated.
  • During the inspection, an employee on the production line was observed placing “. . . waste into a trash can under the product line, pushing the waste down into the can with their hand, until their arm from the elbow down was fully in the trash can.” The employee immediately returned to handling cut watermelon chunks without changing or sanitizing gloves.
  • Condensate water formed a puddle on the floor at one of the entrances to the receiving cooler, a potential reservoir for Listeria, which could be tracked into the rest of the facility.

Caito’s production facility was inspected again by FDA in 2018, in response to an outbreak of Salmonella Adelaide infections linked to freshcut melon products. That outbreak sickened 77 individuals in nine states.

On April 12 this year, Caito recalled various pre-cut melons and fruit medley products after the products were linked to cases of salmonellosis. As of April 24, there were 117 confirmed patients in the 10-state outbreak. At least 32 of the patients have been admitted to hospitals, according to an update this week from the Centers for Disease Control and Prevention.

The FDA is conducting an on-going investigation to determine the cause of the outbreak, including a traceback investigation to determine, if possible, a farm of origin for the melons. According to an agency spokesperson, FDA’s inspection of Caito’s production plant is still in progress.

Recalls and Alerts: April 21 – 24, 2019

Here is today’s list of food safety recalls, product withdrawals, allergy alerts and miscellaneous compliance issues. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

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United States

OUTBREAK ALERT UPDATE: CDC reports 117 cases of Salmonella Carrau in 10 states. Thirty-two people have been hospitalized. The illnesses have been linked to pre-cut melons supplied by Caito Foods LLC. On April 12, 2019, Caito Foods, Inc. recalled pre-cut watermelon, honeydew melon, cantaloupe, and pre-cut fruit medley products containing one of these melons produced at the Caito Foods LLC facility in Indianapolis, Ind.

OUTBREAK ALERT UPDATE: CDC reports 156 cases of E. coli O103 in 10 states. Twenty people have been hospitalized. The illnesses are associated with consumption of ground beef from several different grocery stores and restaurants. Many ill people bought large trays or chubs of ground beef from grocery stores and used the meat to make dishes like spaghetti sauce and sloppy joe.

Food Safety Recall: K2D Foods, doing business as (DBA) Colorado Premium Foods recalls approximately 113,424 pounds of raw ground beef products that may be contaminated with E. coli O103. Please refer to the recall notice for a complete list of affected products, which were shipped to distributors in Port Orange, Fla. and Norcross, Ga. for further distribution to restaurants.


Food Safety Recall Update: Golden Pearl Mushrooms Ltd. recalls GPM brand Pea Shoots (100g, 230g, 455g; Product batch code 10851) due to Listeria monocytogenes contamination. The recalled products were distributed to retailers in Alberta, British Columbia, and Saskatchewan, and may also have been sold elsewhere in Canada.


Food Safety Recall (France): Manufacturer recalls EARL Le Moulin de la Fosse brand Fromages fermiers / farm cheeses (Sold between 2/04 and 20/04/2019) due to E. coli O157:H7 contamination. Please refer to the recall notice for specific information on where the recalled products were sold.

Asia, Africa and the Pacific Islands

Allergy Alert (Israel): Angel Jasmine Bakery Shop recalls chocolate flavored balls and chocolate paste filled crunchy cookies (300g; Expiry 1.6.19) due to incorrect allergen labeling regarding presence of egg and peanuts.

Allergy Alert (Israel): Meshek Melamed Ltd. recalls Beyond burger, plant-based meat (2 x 113g; Expiry 01.10.19) due to undeclared gluten and soy.