RTE Granola Facility Issued Warning Letter in Wake of Salmonella-related Recall

FDA issued a Warning Letter to PepsiCo for their Quaker Oats  manufacturing facility located in Danville, IL, a facility that manufactures RTE granola bars and RTE cereals.  This facility issued a recall of product for Salmonella in December of 2023.  In April of 2024, the facility was closed.

Noted in the report was timing, which is interesting.

• On November 22 and 23, 2023, you collected a (b)(4) sample of “Chewy Chocolate Chip Granola Bars” from Chewy Line (b)(4), which was reported as a presumptive positive on November 25, 2023.
• The positive sample was later confirmed on December 11, 2023, following an investigation of a suspected (but not confirmed) laboratory error concerning the initial results. 
• On December 12, 2023, your corporate Research & Development laboratory in Plano, TX, confirmed the finished product sample as positive for Salmonella Cubana and that the isolate matched (via (b)(4)) previous isolates identified in the facility during your routine environmental monitoring of areas upstream to Chewy Lines (b)(4) on as recently as September 7 and October 4, 2023, near the (b)(4) and the RTE area on the (b)(4) floor, respectively. 
• On December 14, you notified FDA of your decision to recall specific granola bars and granola cereals due to the potential of being contaminated with Salmonella and filed an RFR report.
• On December 19, 2023, FDA collected samples (environmental swabs) of your production environment. FDA analysis of sample INV 1234817 confirmed one swab was positive for Salmonella spp. The swab was collected in a crack on the floor in the (b)(4); the investigator noted that apparent food residue was observed at the sampling location. Whole genome sequencing (WGS) was conducted on the Salmonella isolate obtained from the FDA environmental swabs. The WGS analysis confirmed the isolate to be Salmonella Cubana and the isolate did not match other food, environmental, or clinical isolates in the database. 
• January 3, 2024 - We advised you of the WGS results via a conference call on January 3, 2024. You acknowledged that you had identified historical isolates of Salmonella Cubana in your facility since at least 2020. These findings may indicate that the same strain of Salmonella Cubana has survived since 2020.
• On January 11, 2024, your laboratory analysis identified that Salmonella Cubana that originated in the (b)(4) Room and contaminated the granola line had spread to (b)(4) areas of the extruded RTE cereal line, (b)(4). This included areas where extruded material is exposed to the environment without an additional kill-step. That same day you expanded your recall to cover all RTE cereals, bars, and snacks within shelf-life manufactured at the Danville facility or manufactured with ingredients manufactured at the Danville facility.

Items to note:

• A long delay from presumptive positive to confirmed...about two weeks.
• Had found previous environmental positives from the RTE area - "the isolate matched (via (b)(4)) previous isolates identified in the facility during your routine environmental monitoring of areas upstream to Chewy Lines (b)(4) on as recently as September 7 and October 4, 2023, near the (b)(4) and the RTE area on the (b)(4) floor, respectively. But the organism had been in the facility since 2020.

Issues

• One of the biggest issues was lack of proper corrective action.  "records of corrective actions included cleaning/sanitizing the affected area and additional (b)(4) swabbing,  but they did not include corrective actions that that would have reduced the likelihood that the problem would recur. For example, your “Pathogen Environmental Monitoring (PEM)” investigation worksheet dated September 15, 2023, identified potential harborages or niches associated with buildup or water pooling in pathways on the floor under the (b)(4) and at the “sandwich point” (b)(4) in the (b)(4) Room on the (b)(4) floor (zone (b)(4) areas) but did not consider other areas as potential sources of contamination.

{[FDA}  recommend the company consider incorporating WGS as a tool to investigate pathogen isolates obtained in the environmental monitoring program and/or  finished product testing program. The use of WGS to analyze and investigate any pathogen isolated from your production environment or RTE food products would provide the most complete information available to identify and implement appropriate and effective corrective actions, including steps to prevent the contamination from recurring and steps to ensure contaminated product does not enter commerce.

• GMPs were also an issue - plant equipment and utensils used in manufacturing and processing were not designed and of such material and workmanship as to be adequately cleanable, or adequately maintained to protect against contamination

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pepsico-inc-679972-06122024
WARNING LETTER
PepsiCo, Inc.

MARCS-CMS 679972 — JUNE 12, 2024

Jarred Tahini Recalled After Testing Finds Salmonella

AB World Foods US, Inc. of Oakbrook Terrace, Illinois, is voluntarily recalling Al’Fez Natural Tahini in 5.6oz glass jars because it has the potential to be contaminated with Salmonella.  To date, AB World Foods US, Inc. has received no reports of illness related to the recalled product from consumers in the United States.  The potential for contamination was noted after testing by the company revealed the presence of Salmonella. The company has ceased distribution of the product as the company continues their investigation.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ab-world-foods-us-inc-recalls-alfez-natural-tahini-because-possible-health-risk
AB World Foods US, Inc. Recalls Al’Fez Natural Tahini Because of Possible Health Risk
Summary
Company Announcement Date:  July 12, 2024
FDA Publish Date:  July 12, 2024
Product Type:  Food & Beverages 
Reason for Announcement: Potential to be contaminated with Salmonella
Company Name:  AB World Foods US, Inc.
Brand Name:  Al’Fez
Product Description:  Tahini

Overseas Operations Using Potentially Contaminated Cooking Oil

A Chinese state media investigation found "tank trucks were delivering chemicals and edible oil interchangeably without cleaning."  "The furor follows a bombshell investigation published on July 2 by the state media outlet Beijing News, which found multiple cases of tank trucks transporting edible cooking oil immediately after delivering chemicals used for coal-to-liquid processing."

It appears that this is a widespread issue done primarily for cost savings.

In HACCP or Preventive Controls training, we discuss the need to reevaluate your plan when new information becomes available.  This would be the type of issue that when you learn about, you check to see whether this issue impacts your own operation.  Perhaps you are buying imported oil roasted nuts or frozen pre-fried breaded chicken nuggets.   Does this issue affect those items?

https://www.msn.com/en-us/news/world/china-is-freaking-out-over-an-open-secret-that-its-cooking-oil-was-ferried-for-years-in-chemical-tanks-that-weren-t-cleaned/ar-BB1pE693
China is freaking out over an 'open secret' that its cooking oil was ferried for years in chemical tanks that weren't cleaned
Story by mloh@businessinsider.com (Matthew Loh) • 15h

China has been hit by another major food scandal, this time involving cooking oil in chemical tanks.

Oregon Firm Recalls Potato Salad Due to Foreign Material - Hard Plastic

Reser’s Fine Foods Beaverton, OR is voluntarily recalling Hill Country Fare Mustard Potato Salad 48oz (3LB) with a Use By Date of JUL/26/24 due to the possibility of pieces of hard plastic foreign material in the package. 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/resers-fine-foods-announces-voluntary-recall-hill-country-fare-mustard-potato-salad-use-date-jul2624
Reser’s Fine Foods Announces Voluntary Recall of Hill Country Fare Mustard Potato Salad With a Use By Date of JUL/26/24
Summary
Company Announcement Date:  July 02, 2024
FDA Publish Date:  July 09, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Potential Hard Plastic Foreign Material
Company Name:  Reser’s Fine Foods
Brand Name:  Hill Country Fare
Product Description:  Mustard Potato Salad

Owner of NY Cheese Operation Sentenced for 2016/2107 Listeria Outbreak

The owner of a NY cheese company was sentenced this week for his company's failure to protect product from Listeria contamination which resulted in an Listeria outbreak in 2016 thru 2017.  This outbreak resulted in the death of two people and hospitalization of two others.

Vulto Creamery of Walton, NY has been shut down.  The recall was initiated in March of 2017 and then expanded to include all raw milk cheese a few weeks later.  FDA issued a report of the investigation of the facility in April of 2017.  A summary of the FDA findings includes:

• LM was all over the plant, on food contact equipment, and on product.
• While the plant did testing and found Listeria species, they did NOTHING beyond re-clean the area. They did not do follow-up testing nor did they try to determine where the Listeria was coming from, whether is was LM, or whether it impacted product.
• They followed poor sanitary practices including not properly washing hands
• Poor cleaning of facility and equipment
• Poor design and maintenance of the facility

Johannes Vulto, founder and owner of Vulto Creamery LLC based in Walton, was sentenced to three years probation and ordered to pay a $100,000 fine, along with 240 hours of mandated community services.

Binghamtonhomepage.com
https://www.binghamtonhomepage.com/delaware-county/vulto-creamery-founder-sentenced-for-deadly-cheese/
Vulto Creamery founder sentenced for deadly cheese
by: Spencer Gustafson
Posted: Jul 9, 2024 / 04:23 PM EDT
Updated: Jul 9, 2024 / 05:20 PM EDT

Canadian Establishment Recalls RTE Chicken Products After USDA Detects Listeria

Al-Safa US LLC, the importer of record located in Mississauga, Ontario, Canada, is recalling approximately 2,010 pounds of imported frozen ready-to-eat chicken products that may be adulterated with Listeria monocytogenes.  The problem was discovered after FSIS performed routine product testing and the results indicated the product may be contaminated with Listeria monocytogenes.

https://www.fsis.usda.gov/recalls-alerts/al-safa-us-llc-recalls-frozen-ready-eat-chicken-products-due-possible-listeria
Al-Safa US LLC Recalls Frozen Ready-To-Eat Chicken Products Due to Possible Listeria Contamination

WASHINGTON, July 5, 2024 – Al-Safa US LLC, the importer of record located in Mississauga, Ontario, Canada, is recalling approximately 2,010 pounds of imported frozen ready-to-eat chicken products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Oregon Facility Recalls Various Non-alcoholic Mixes Due to Non-compliance Issues

Urban River Spirits is issuing a voluntary recall of various non-alcoholic mixers and spritzes to additional shelf stability testing requirements from the Oregon Department of Agriculture.  Urban Spirits is issuing a voluntary recall of these Urban Spirits non-alcoholic drink mixes due to being produced in an unlicensed and uninspected facility. The product safety is undetermined due to potential under-processing. The product is packaged in 750 mL glass bottles.

Hopefully the pH is sufficiently low and the product amply heated to eliminate vegetative pathogens and spoilage organisms, including yeast.  But who knows...certainly not the State inspection folks.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/urban-spirits-issues-voluntary-recall-urban-spirits-non-alcoholic-drink-mixes-due-potential-under
Urban Spirits Issues Voluntary Recall of Urban Spirits Non-Alcoholic Drink Mixes Due to Potential Under-Processing
Summary
Company Announcement Date:  July 02, 2024
FDA Publish Date:  July 03, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Potential for under-processing
Company Name: Urban River Spirits
Brand Name:  Urban River Spirits
Product Description:  Nonalcoholic drink mixes

Delta Flight to Europe Diverted Back to NY After Crew and Passengers Served Moldy Food

A Delta flight to Amsterdam from NY was diverted back to NY after it was discovered that chicken served on the flight was moldy.

"We were probably halfway to Amsterdam, around Nova Scotia and starting to cross ocean when the pilot came on and said there was some type of food issue,' Kirchoff recalled."

There were no apparent ill effects according to this report.

"There were 24 aided cases upon landing, including 10 members of the flight crew and 14 passengers, all of whom declined to receive medical attention,' a Port Authority spokesperson told DailyMail.com."

In the end, it was better that precautionary actions were taken.  If the product had mold indicating potential temperature abuse, no telling what else could have been present, including the risk of Staphylococcus growth and toxin formation.

But this is not a good compliance to food safety procedures for the Delta foodservices.

Daily Mail.com
https://www.dailymail.co.uk/news/article-13597279/Delta-flight-ill-served-moldy-chicken-pilots.html
I was on the Delta flight where 24 people fell ill including both pilots… after they served moldy chicken
By NATASHA ANDERSON FOR DAILYMAIL.COM

PUBLISHED: 11:46 EDT, 3 July 2024 | UPDATED: 13:18 EDT, 3 July 2024

'They said they saw some mold on the chicken,' she added. 'I asked if anyone had gotten sick and they told us no one had been affected, but the pilots both ate the chicken.'

Salmonella Outbreak Linked to Cucumbers - Outbreak Strain Found in Grower's Canal Water

Bedner Growers, Inc. in Florida has been identified as the source of Salmonella contaminated cucumbers that have caused 449 reported cases of illness.  FDA found the outbreak Salmonella strains in the canal water.

"FDA collected samples at the grower in Florida and identified Salmonella Braenderup in untreated canal water. WGS determined that the Salmonella found in the water is the same strain of Salmonella Braenderup that made people in this outbreak sick. Additional soil and water samples collected at Bedner Growers, Inc. were positive for other strains of Salmonella. CDC and FDA are looking to see if these strains have caused illness in people."

Of the 449 reported cases, 125 people have been hospitalized.

"As of July 2, a total of 449 people infected with one of the outbreak strains of Salmonella Africana and Salmonella Braenderup have been reported from 31 states and the District of Columbia (see map). Of these illnesses, 215 people were infected with the newly added Salmonella Braenderup strain. Illnesses started on dates ranging from March 11, 2024, to June 4, 2024 (see timeline). Of 360 people with information available, 125 have been hospitalized and no deaths have been reported."

CDC
https://www.cdc.gov/salmonella/africana-06-24/index.html
Salmonella Outbreak Linked to Cucumbers
Posted July 2, 2024

Fast Facts
Illnesses: 449 (38 new Africana, 215 Braenderup new)
Hospitalizations: 125 (11 new Africana, 50 Braenderup new)
Deaths: 0
States: 31 states and the District of Columbia (1 new Africana, 26 Braenderup)
Recall: Yes
Investigation status: Active (first posted on June 5, 2024)

Outbreak Investigation Summary
Epidemiologic, traceback, and laboratory data show that cucumbers were contaminated with Salmonella and made people sick. Testing identified the Salmonella Braenderup strain in untreated canal water used by a grower in Florida. Cucumbers from this grower are no longer in season and any sold previously are no longer on shelves.