FDA Issues Warning Letter to SC Processor for Continued Listeria Presence

FDA issued a Warning Letter to Discover Fresh Foods, LLC of Greenville, SC, a manufacturer of refrigerated ready-to-eat (RTE) dips and spreads.  This issue is that the company had a ongoing contamination issue of the same Listeria strain.

According to the report, FDA laboratory analysis of environmental sample #1242488 collected on December 13, 2023, found that three (3) out of the 99 total environmental swabs were positive for L. monocytogenes. The positive swabs were recovered from non-food-contact surfaces in Production Room (b)(4), and (b)(4)) during the production of Taste of the South Fried Pickle Dip, and the underside of the top level of the red cart in (b)(4). FDA laboratory analysis of sample #1242488 also found three (3) out of the 99 swabs were positive for Listeria innocua (L. innocua). These swabs were obtained from the (b)(4) transfer pump bottom frame, trash bin wheel, and bottom of sanitation squeegee.

The same organism had been found in the 

• three (3) L. monocytogenes isolates obtained from FDA environmental sample 124288 in 2023;
• four (4) L. monocytogenes isolates obtained from USDA FSIS environmental samples in 2023;
• one (1) L. monocytogenes isolate obtained from Buffalo Style Chicken Dip collected by USDA FSIS in 2023;
• two (2) L. monocytogenes isolates obtained from USDA FSIS environmental samples in 2018;
• one (1) L. monocytogenes isolates obtained from Buffalo Style Chicken Dip collected by USDA FSIS in 2018; and
• one (1) L. monocytogenes isolate obtained from Chipotle Chicken Salad collected by FDACS in 2017.

Based on these results of the WGS analysis, the twelve (12) isolates represent a single strain of L. monocytogenes. The presence of the same strain of L. monocytogenes over multiple years indicates that there has been a resident pathogen in the facility since at least November 2017. 

Then in 2024, additional sampling by USDA found Listeria.  "USDA FSIS notified FDA L. monocytogenes was detected in two (2) additional environmental swabs collected from non-food-contact surfaces (e.g., cart wheels) at [the] facility".  The company got rid of a chopper that they felt was the source, however, is the issue resolved?   When contamination becomes then endemic within a facility, it can now be very wide spread, locating in numerous niches.

It is surprising that USDA was not more aggressive, and for that matter, the company was not more aggressive in solving this issue.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/discover-fresh-foods-llc-677021-06262024
Discover Fresh Foods, LLC
MARCS-CMS 677021 — JUNE 26, 2024

KY Establishment Recalls Hot Dog Products Produced Without USDA Inspection

AW Farms, an Argillite, Ky., establishment, is recalling approximately 6,900 pounds of hot dog products that were produced without the benefit of federal inspection,  The problem was discovered when FSIS was notified by a state public health partner about these products. FSIS investigated and determined that the hot dog products were produced and distributed without the benefit of federal inspection.

https://www.fsis.usda.gov/recalls-alerts/aw-farms-recalls-ready-eat-hot-dog-products-produced-without-benefit-inspection
AW Farms Recalls Ready-To-Eat Hot Dog Products Produced Without Benefit of Inspection

WASHINGTON, July 15, 2024 – AW Farms, an Argillite, Ky., establishment, is recalling approximately 6,900 pounds of hot dog products that were produced without the benefit of federal inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Oregon Firm Recalls Sausage Products Due to Undeclared Soy

Taylor's Sausage, Inc., a Cave Junction, Ore., establishment, is recalling approximately 74 pounds of ready-to-eat Landjaeger sausage products due to misbranding and undeclared allergens.  The product contains soy, a known allergen, which is not declared on the product label.  The problem was discovered during routine FSIS in-plant verification activities when FSIS personnel observed that soy, a known allergen, was being used as an ingredient and was not declared on the finished product label.

https://www.fsis.usda.gov/recalls-alerts/taylors-sausage-inc--recalls-ready-eat-landjaeger-sausage-products-due-misbranding
Taylor's Sausage, Inc. Recalls Ready-To-Eat Landjaeger Sausage Products Due to Misbranding and Undeclared Allergens

WASHINGTON, July 13, 2024 - Taylor's Sausage, Inc., a Cave Junction, Ore., establishment, is recalling approximately 74 pounds of ready-to-eat Landjaeger sausage products due to misbranding and undeclared allergens, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today. The product contains soy, a known allergen, which is not declared on the product label.

Ohio Distributor Recalls Cucumbers After State Testing Finds Listeria

Wiers Farm Inc. of Willard, OH, is voluntarily recalling a limited number of whole cucumbers with a pack date of June 5, 2024 and bagged salad cucumbers with a pack date of June 5, 2024 and June 6, 2024 due to possible contamination with Listeria monocytogenes. This product was not grown or harvested by Wiers Farm. It was sourced from out of state, then handled and distributed by Wiers Farm. Wiers Farm Inc. is coordinating closely with regulatory officials in connection with the recall.  The potential contamination was discovered by the Michigan Department of Agriculture and Rural Development (MDARD) through routine sampling.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wiers-farm-inc-issues-voluntary-recall-whole-and-salad-cucumbers-due-possible-contamination-listeria
Wiers Farm, Inc Issues a Voluntary Recall on Whole and Salad Cucumbers Due to Possible Contamination with Listeria
Summary
Company Announcement Date:  July 12, 2024
FDA Publish Date:  July 16, 2024
Product Type:  Food & Beverages  Vegetable Products
Reason for Announcement:  Potential to be contaminated with Listeria monocytogenes
Company Name:  Wiers Farm, Inc.
Brand Name:  Wiers Farm
Product Description:  whole cucumbers and bagged salad

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