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.

Cut melons from Caito Foods linked to multistate Salmonella outbreak


Caito Foods LLC (Caito) is recalling fresh cut watermelon, honeydew melon, cantaloupe and fresh-cut mixed fruit containing one of these melons due to potential Salmonella contamination.

The cut fruit was produced at the company’s facility in Indianapolis, Indiana.

According to the US Centers for Disease Control and Prevention (CDC), cut melons supplied by Caito are the likely source of a multistate outbreak of Salmonella Carrau infections that caused 93 illnesses in 9 states.

Twenty-three people have been hospitalized so far in the outbreak that began on March 4, 2019. The most recent reported illness was dated March 31, 2019. No deaths have been reported.

Confirmed cases of Salmonella Carrau associated with this outbreak have been reported in Alabama (1), Illinois (5), Indiana (18), Kentucky (16), Michigan (19), Minnesota (3), Missouri (3), Ohio (27), and Wisconsin (1).

Caito cut melon products were linked to the outbreak through epidemiological and traceback evidence.

The company has suspended production and distribution and is cooperating with the US Food and Drug Administration (FDA) investigation.

According to CDC, most people infected with Salmonella develop diarrhea, fever, and stomach cramps 12 to 72 hours after being exposed to the bacteria. The illness usually lasts 4 to 7 days.  Children, seniors and people with weakened immune systems are more likely to have a severe illness.

This is the second time in less than a year that cut melons produced by Caito were associated with a Salmonella outbreak. 

An outbreak of Salmonella Adelaide that sickened 77 people in 9 states between April 30, 2018 and July 2, 2018 was linked to cut melon products from Caito’s Indianapolis facility. Thirty-six people were hospitalized. 

The following recalled products were packaged in clear, plastic clamshell containers, and were distributed in Illinois, Indiana, Iowa, Kansas, Kentucky, Michigan, Minnesota, Missouri, Nebraska, New York, North Carolina, Ohio, Pennsylvania, Tennessee, West Virginia, and Wisconsin.

Caito Foods Distribution (Plant identifier code SN01); States affected: IL, IN, KY, MI, MO, NY, OH, PA, NC; Clear Generic Label Distributed by Caito Foods; Best by/Use by 4/18/2019 and any date prior

CANTALOUPE SPEARS, 16 oz. UPC 81851301294

HONEYDEW SPEARS, 16 oz. UPC 81851301300

MELON MIX, 10 oz. UPC 81851301331

FRUIT MIX, 10 oz. UPC 81851301348

HONEYDEW CHUNKS, 10 oz. UPC 81851301362

CANTALOUPE CHUNKS, 10 oz. UPC 81851301379

WATERMELON CHUNKS, 9.5 oz. UPC 81851301386

FRUIT BURST, 20 oz. UPC 81851301409

FRUIT MIX, 48 oz. UPC 81851301416

FRUIT MIX, 16 oz. UPC 81851301447

FRUIT SNACK TRAY, 32 oz. UPC 81851301454

FRUIT PARTY PLATTER, 64 oz. UPC 81851301461

MELON MIX SPEARS, 16 oz. UPC 81851301478

FRUIT BOWL, 64 oz. UPC 81851301485

WATERMELON SPEAR, 16 oz. UPC 81851301591

CANTALOUPE CHUNKS, 80 oz. UPC 81851301614

HONEYDEW CHUNKS, 80 oz. UPC 81851301621

FRUIT MIX, 80 oz. UPC 81851302079

WATERMELON CHUNKS, 80 oz. UPC 81851302147

FRUIT BURST, 10 oz. UPC 81851302215

CANTALOUPE CHUNKS, 6 oz. UPC 81851217441

FRUIT MIX CHUNK, 6 oz. UPC 81851222308

WATERMELON CHUNK, 6 oz. UPC 81851222360

FRUIT SALAD SEASONAL, 10 oz. UPC 81851223411

FRUIT SALAD SEASONAL, 20 oz. UPC 81851223442

FRUIT SALAD SEASONAL, 32 oz. UPC 81851223466

FRUIT SPEAR SEASONAL, 16 oz. UPC 81851272662

CANTALOUPE CHUNK, 6 oz. UPC 81851272716

CANTALOUPE CHUNK, 10 oz. UPC 81851272723

FRUIT BURST, 10 oz. UPC 81851272778

FRUIT MIX, 10 oz. UPC 81851272785

MELON MIX, 10 oz. UPC 81851272815

MIXED FRUIT CHUNK, 6 oz. UPC 81851272822

SEASONAL FRUIT SALAD, 10 oz. UPC 81851272914

SEASONAL FRUIT SALAD, 32 oz. UPC 81851272921

WATERMELON SPEAR, 16 oz. UPC 81851273010

WATERMELON CHUNK, 18 oz. UPC 81851273041

WATERMELON CHUNK, 6 oz. UPC 81851273058

WATERMELON CHUNK, 9.5 oz. UPC 81851273065

WATERMELON TRAY, 80 oz. UPC 81851302239

WATERMELON CHUNK, 18 oz. UPC 826766260317

Gordon Food Service (Plant identifier code SN01); States affected IN, MI, PA, WI, KY, OH; Clear Generic Label Distributed by Caito Foods; Best by/Use by 4/18/2019 and any date prior

WATERMELON CHUNKS, 5 oz. UPC 826766009800

CANTALOUPE CHUNKS, 5 oz. UPC 826766009817

FRUIT MIX, 4.5 oz. UPC 826766257676

WATERMELON CHUNK, 10 oz. UPC 826766260041

MELON MIX, 5 oz. UPC 826766009886

Kroger (Plant identifier code GHMW); States affected: IL, IN, KY, MI, OH, TN, WV; Clear Generic Label Distributed by Renaissance Food Group; Best by/Use by 4/14/2019 and any date prior

MELON MIX, 10 oz. UPC 826766139804

FRUIT TRAY SM, 26.75 oz. UPC 826766145386

HONEYDEW CHUNK, 10 oz. UPC 49022558632

WATERMELON SPEAR, 16 oz. UPC 826766139620

WATERMELON CHUNK, 10 oz. UPC 826766139859

CANTALOUPE CHUNK, 80 oz. UPC 826766896578

CANTALOUPE CHUNK, 10 oz. UPC 826766140008

CANTALOUPE CHUNK, 24 oz. UPC 826766140060

MELON MIX, 24 oz. UPC 826766140077

WATERMELON CHUNK, 24 oz. UPC 826766140084

WATERMELON CHUNK, 48 oz. UPC 826766140145

FRUIT SNACK TRAY, 40 oz. UPC 826766140152

FRUIT MEDLEY, 10 oz. UPC 826766140176

FRUIT MEDLEY, 24 oz. UPC 826766140244

FRUIT MEDLEY, 48 oz. UPC 826766140305

WATERMELON CHUNK, 80 oz. UPC 826766896011

WATERMELON SPEAR, 64 oz. UPC 826766181704

MIXED SPEARS, 16 oz. UPC 826766139606

MELON SPEAR TRIO, 16 oz. UPC 826766139590

FRU TRAY LG, 64.75 oz. UPC 826766185498

HONEYDEW CHUNK, 80 oz. UPC 826766898947

Kroger (Plant identifier code GHMW); States affected: IL, IN, KY, MI, OH, TN, WV; Clear Generic Label Distributed by Renaissance Food Group; Best by/Use by 4/18/2019 and any date prior

FRUIT SALAD SEASONAL, 80 oz. UPC 826766898985

Kroger (Plant identifier code GHMW); States affected: IL, IN, KY, MI, OH, TN, WV; Boar’s Head Private Label; Best by/Use by 4/13/2019 and any date prior

SNACKER ITALIAN SALAMI, 4.75 oz. UPC 826766951246

SpartanNash Distribution (Plant identifier code SN01); States affected: MI, IN, IL; Open Acres; Best by/Use by 4/18/2019 and any date prior

CANTALOUPE SPEAR, 16 oz. UPC 884853630856

FRUIT BURST, 10 oz. UPC 884853630887

MELON MIX, 10 oz. UPC 884853630894

FRUIT MIX, 10 oz. UPC 884853630900

HONEYDEW CHUNK, 10 oz. UPC 884853630924

CANTALOUPE CHUNK, 10 oz. UPC 884853630931

WATERMELON CHUNK, 9.5 oz. UPC 884853630948

FRUIT BURST, 20 oz. UPC 884853630955

FRUIT MIX, 48 oz. UPC 884853630962

MELON MIX, 16 oz. UPC 884853630986

FRUIT MIX, 16 oz. UPC 884853630993

FRUIT TRAY, 32 oz. UPC 884853631006

FRUIT PARTY PLATTER, 64 oz. UPC 884853631013

WATERMELON SPEAR, 16 oz. UPC 884853631068

WATERMELON SPEAR, 28 oz. UPC 884853630672

FRUIT BOWL, 64 oz. UPC 884853631235

Target (Plant identifier code GHMW); States affected: IL; Garden Highway Label; Best by/Use by 4/18/2019 and any date prior

FRUIT BURST, 50 oz. UPC 826766951796

FRUIT BURST, 10 oz. UPC 826766951079

Target (Plant identifier code GHMW); States affected: IL; Garden Highway Label; Best by/Use by 4/19/2019 and any date prior

WATERMELON CHUNK, 9.5 oz. UPC 826766951031

FRUIT SNACK TRAY, 32 oz. UPC 826766951789

CANTALOUPE CHUNK, 10 oz. UPC 826766951048

MELON MIX, 20 oz. UPC 826766950898

CANTALOUPE SPEAR, 16 oz. UPC 826766951109

WATERMELON SPEAR, 16 oz. UPC 826766951093

CANTALOUPE CHUNK, 20 oz. UPC 826766951758

Trader Joes (Plant identifier code P-003); States affected: IA, IL, IN, KS, KY, MI, MN, MO, NE, OH, WI; Trader Joes; Best by/Use by 4/19/2019 and any date prior

CANTALOUPE SLICE, 16 oz; UPC 95266

Walmart (Plant identifier code GHMW); States affected: IA, IL, IN, MO, OH, MI; Freshness Guaranteed; Best by/Use by 4/19/2019 and any date prior

CANTALOUPE SPEAR, 10 oz. UPC 681131180146

SEASONAL TRIO, 32 oz. UPC 681131180696

WATERMELON SPEAR, 32 oz. UPC 681131180689

SEASONAL BLEND, 10 oz. UPC 681131180481

SEASONAL BLEND, 16 oz. UPC 681131180498

WATERMELON SPEAR, 10 oz. UPC 681131180672

WATERMELON SPEAR, 16 oz. UPC 681131180665

FRUIT BOWL, 40 oz. UPC 681131180238

CANTALOUPE SPEAR, 16 oz. UPC 681131180153

WATERMELON CHUNK, 40 oz. UPC 681131180658

SEASONAL BLEND, 32 oz. UPC 681131180504

FRUIT TRAY, 48 oz. UPC 681131180207

Amazon/Whole Foods (Plant identifier code GHMW); States affected: IL, WI; Whole Foods Market Label; Best by/Use by 4/18/2019 and any date prior

WATERMELON CHUNKS, 9.5 oz. UPC 826766810956

CANTALOUPE CHUNKS, 10 oz. UPC 826766811045

WATERMELON SPEARS, 16 oz. UPC 826766810970

MELON COMBO, 20 oz. UPC 826766811205

FRUIT TRAY SMALL, 36 oz. UPC 826766811274