FDA Issues Warning Letter to GA Egg Facility After Many Salmonella Positive Environmental Samples

FDA issued a Warning Letter to Rise N’ Shine Farm, Inc., a shell egg farm and egg processing facility, where eggs are washed and packed, located in Calhoun, Georgia

FDA conducted environmental sampling and found "19 isolates from the three samples represent two strains of Salmonella enterica. The first strain includes 17 isolates derived from swabs collected from your poultry house (FDA Sample 1231486) that match 57 clinical isolates and demonstrates that this strain is capable of causing human illness. This strain also matches an isolate obtained from a chicken sample collected in Georgia in 2021. The second strain consisted of two environmental isolates derived from swabs collected from your poultry house (FDA Sample 1231467) and your egg processing environment (FDA Sample 1240106) that match 23 clinical isolates, demonstrating that this strain is also capable of causing human illness. This strain also matches five isolates obtained from chicken samples collected in Georgia and Illinois in 2023. We advised you of the importance of these WGS results on November 20, 2023."

• Did not have and implement a written Salmonella Enteritidis prevention plan (SE plan) that was specific to your farm and includes the minimum SE prevention measures
• Did not conduct environmental testing of the pullet environment at 14-16 weeks of age, as required 
• id not conduct environmental testing for SE in your poultry house when each group of laying hens were 40 to 45 weeks of age
• Did not prevent stray poultry, wild birds, cats, and other animals from entering poultry houses, as required by 21 CFR 118.4(b)(4). Specifically, during the inspection three dogs were observed inside your poultry house, where they also had access to the pasture area outside the poultry house.
• did not register your farm as shell egg producer, as required per 21 CFR 118.11(a). At the initiation of the inspection, your farm had 3,000 or more laying hens, was producing shell eggs for the table market, and was not selling all the eggs directly to consumers.
• Eggs were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health within the meaning of section 402(a)(4) of the FD&C Act. Specifically, during the inspection, our investigators observed the following conditions and practices at your farm during the processing of shell eggs:
• Leftover product grime was observed on the egg candling line before processing.
• Rust observed on areas adjacent to food contact surface points on your processing line.
• Egg line brushes used to clean eggs were observed with an apparent substance after cleaning.
• Porous wood was used as a brace on a portion of the processing line.
• Duct tape was used as a repair on the egg packing line in areas that come into direct contact with shell eggs.

FSIS Issues Warning for Illegally Imported Yummy Dino Buddies Holiday Chicken Nuggets (from Canada)

The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert for ready-to-eat (RTE) frozen chicken products that did not receive the benefit of import reinspection.  The problem was discovered by FSIS inspection personnel who determined that the products were not presented for FSIS import reinspection.

 A recall was not requested because the products are no longer available for purchase.  And the products were shipped to only one location.  "The products bear the Canadian establishment seal “348.” These items were shipped to one Costco retail location at 7095 Marketplace Dr, Goleta, California, 93117"

https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-ready-eat-frozen-chicken-products-imported-without-0
FSIS Issues Public Health Alert for Ready-To-Eat Frozen Chicken Products Imported Without The Benefit Of Import Reinspection

WASHINGTON, Dec. 4, 2024 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert for ready-to-eat (RTE) frozen chicken products that did not receive the benefit of import reinspection. A recall was not requested because the products are no longer available for purchase.

NC Firm Recalls Hushpuppies Due to Missing Milk Allergen Declaration

Atkinson Milling Company is recalling a variety of Hushpuppies due to undeclared milk allergen.  On November 29, 2024, during an internal review of the label, the firm discovered that they did not have milk listed in the “ingredients” or “contains” sections. Upon this discovery, and out of an abundance of caution, the firm decided to report this labeling error to North Carolina Department of Agriculture and the Food & Drug Administration.

So this would be an issue with improper label design.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/atkinson-milling-company-recalls-frozen-1-lb-bag-frozen-hushpuppies-onions-2-lb-8oz-bag-frozen
Atkinson Milling Company Recalls Frozen 1 Lb Bag Frozen Hushpuppies with Onions, 2 Lb 8oz Bag Frozen Hushpuppies With Onions and 2 Lb 8oz Bag Frozen Hushpuppies Without Onions Due to Undeclared Milk
Summary
Company Announcement Date:  December 05, 2024
FDA Publish Date:  December 05, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Potential or Undeclared Allergen - Milk
Company Name:  Atkinson Milling Company
Brand Name:  Atkinson’s
Product Description:  Hushpuppies with Onions, Hushpuppies

Update on Salmonella Outbreak Linked to Imported Cucumbers; Additional Distributors Recall Cucumbers

FDA, CDC, and state partners continue to investigate a multistate outbreak of Salmonella Typhimurium infections linked to cucumbers.  FDA is working closely with implicated firms to determine whether additional recalls of American/slicer cucumbers, processed recalled cucumbers, and products made with recalled cucumbers may be necessary. On December 3, 2024, Walmart recalled Marketside Fresh Cut Cucumber Slices sold at stores in TX. On December 4, 2024, JFE, Supreme Produce, and Yummi Sushi initiated recalls of food products containing recalled cucumbers at Kroger stores in AZ, CO, LA, TX, and WY, and King Soopers stores in CO.

There have been no additional cases since reported on November 29, 2024.

Case Counts
Total Illnesses: 68
Hospitalizations: 18
Deaths: 0
Last Illness Onset: November 16, 2024
States with Cases: AK, CA, CO, IA, IL, MA, MT, NE, NJ, NY, OH, OR, PA, SD, TX, UT, WA, WI and WY
Product Distribution*: AK, AZ, AR, CA, CO, CT, FL, ID, IL, IN, IA, KS, LA, MD, MA, MI, MN, MO, MT, NE, NV, NJ, NY, NC, ND, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, and WY
*Distribution has been confirmed for states listed, but product could have been distributed further, reaching additional states


FDA Outbreak Investigation
https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-salmonella-cucumbers-november-2024
Outbreak Investigation of Salmonella: Cucumbers (November 2024)
Do not eat, sell, or serve recalled cucumbers or products containing recalled cucumbers. Multiple companies issue recalls.
Content current as of:
12/05/2024

Current Update
December 5, 2024

FDA Cites Bakery for Preventive Control and GMP Issues

FDA issued a Warning Letter to Mena Food Group, Fort Lauderdale, FL, after inspecting the facility which manufactures ready-to eat (RTE) bakery products including breads, cakes, and pastries.   The issues seen here are things that have been previously cited with other bakery operations, as well as other operations producing RTE foods.

Environmental pathogens considered a hazard requiring a preventive controls - The facility did not identify and evaluate recontamination with environmental pathogens as a known or reasonably foreseeable hazard to determine whether it requires a preventive control. The RTE bakery products are exposed to the environment at post-baking steps at the (b)(4) steps where they can be contaminated with environmental pathogens such as Salmonella and Listeria monocytogenes. The packaged bakery products do not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize pathogens. Therefore, contamination with environmental pathogens is a known or reasonably foreseeable hazard

Environmental monitoring is required - In addition, note that environmental monitoring is required if contamination of an RTE food with an environmental pathogen is a hazard requiring a preventive control (see 21 CFR 117.165(a)(3)). Your facility is not monitoring the environment for an environmental pathogen, or for an appropriate indicator organism, to verify the effectiveness of your sanitation controls.

Need to consider mycotoxins as a hazard in the hazard analysis - The facility did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control. The facility manufactures RTE bakery products (e.g., breads) containing high protein wheat flour, which has been associated with mycotoxins such as deoxynivalenol (DON). Therefore, mycotoxins are a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in your circumstances would identify mycotoxins as a hazard requiring a preventive control in this ingredient. Further, a facility that identifies raw materials and other ingredients that require a supply-chain-applied control, such as mycotoxins, must establish and implement a risk-based supply-chain program for those raw materials and ingredients (see 21 CFR 117.405(a)(1)). The supply-chain program must include using approved suppliers and conducting supplier verification activities (see 21 CFR 117.410). This program was not in place.

Allergen labeling is required - The facility’s written hazard analysis considered undeclared allergens; however, the company determined this to be the responsibility of the customer and the consumer. The  facility manufactures finished products that contain allergens such as wheat, milk, egg, soy (soybean lecithin), coconut, walnuts, and sesame. They are distributed to restaurants, hotels, nursing homes, hospitals, and distributors/wholesalers with labeling that does not include an ingredient statement and allergen declaration.  Examples - the challah burger buns, challah knot rolls, and sesame challah burger buns were staged for distribution in the staging area. They were packaged in pre-printed plastic bags without the wheat, soy, and sesame allergens declared.  The 12-inch hoagie rolls were staged for distribution in the staging area. They were packaged in clear plastic bags that did not declare wheat and soy allergens.

Allergen controls for cleaning to prevent cross contact - Allergen controls procedures for nuts do not ensure protection of food from allergen cross-contact from walnuts, as required by 21 CFR 117.135(c)(2)(i). Specifically, the hazard analysis for various RTE breads, cakes, and pastries identified the hazard of allergen cross-contact at the (b)(4) steps. At these steps, they use shared food-contact equipment and utensils to manufacture bakery products containing different allergen profiles on the same day.

The written allergen preventive control procedure states that “(b)(4)”. However, this procedure was not followed. On October 30, 2023, the rotating round turntable and utensils used by the  employee were not cleaned after handling the RTE pina colada cake (containing wheat, soy, eggs, milk and coconut) and before handling the RTE mocha cake (containing wheat, soy, eggs, and milk but not coconut).

GMP Issues

• A pastry area employee walked outside the firm to her car wearing her hairnet and plastic work apron. She returned to the pastry area without washing her hands or replacing her hairnet and plastic apron.
• A cake room employee wearing a hairnet, gloves, and plastic apron was observed preparing raw chocolate cigars. He exited the cake room door leading to the outside. A few moments later he returned through the same exterior door wearing a hairnet, gloves, apron, and the facemask. He immediately returned to preparing raw chocolate cigars without washing his hands and changing his hairnet, gloves, and plastic apron.
• A bearded pastry area employee mixing RTE frosting/icing was using his gloved hand to transfer the frosting to another bowl. While he was transferring the frosting, part of his bare arm/arm hair came in direct contact with the frosting. Also, this employee was wearing a beard cover; however, it was pulled down under his chin during the transferring of the frosting.
• In your pastry room and cake room, employees did not wash their hands or gloves after touching their face.
• Open beverage bottles were observed 1) In the bread processing area, under the preparation tables, while the employees were manipulating raw dough; 2) In the pastry area, under preparation tables, while the employees were manipulating in-process products; 3) Inside the pastry area reach-in freezer, where ingredients, in-process, and finished products are stored.
• In the cake room, your facility has a black multi-drawer toolbox where utensils (e.g., spatulas, knives, cake cutting wire) are stored after they are cleaned. These utensils are taken from the toolbox and immediately used to decorate and cut RTE cake room products. The toolbox contained personal items such as glasses, keys, and opened beverage bottles.
• The plant was not maintained  in a clean and sanitary condition and in adequate repair, as required by 21 CFR 117.35(a). Specifically: a. the fluorescent light located directly above the processing tables appeared to have a black mold-like substance on the light diffusers. Adjacent ceiling tiles were also observed with an apparent similar substance, and b. On  two large fans in the cutting and packing room were observed to have excessive filth and debris on the metal wire fan guard.  The fans were observed blowing onto RTE uncovered cupcakes on a pan rack cart.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mena-food-group-llc-673814-08082024
Mena Food Group, LLC
MARCS-CMS 673814 — August 08, 2024

FDA Issues Warning Letter to Produce Packer for Noncompliance In Providing Toilet Facilities in the Fields

FDA conducted a domestic investigation at your papaya packing and holding operation.  FDA issued a Warning Letter to the company for not providing personnel with adequate, readily accessible toilet facilities, including toilet facilities readily accessible to growing areas during harvesting activities,
FDA investigators observed inaccessible toilets. During this inspection, the person stated that the toilet facility, located approximately 0.30 miles away from the picking location, was too far. He also stated that harvest employees urinate in the bush area adjacent to the papaya field because the toilets are too far away. (b)(4) noted that the toilet facility is provided and maintained by the packer.

The packer in this case contracts the farms, and with that, the company stated they "have committed to not only provide all of your contracted growers and harvesters with adequate, readily accessible toilet facilities, but also to provide the supplies and maintenance for those facilities."

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/calavo-growers-inc-687785-10252024
Calavo Growers, Inc.
MARCS-CMS 687785 — October 25, 2024

USDA FSIS Issues Health Alert for Pork Products Imported from Ineligible Country, Ecudador

The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert for frozen ready-to-eat pork mortadella products that may have been illegally imported from Ecuador, a country ineligible to export meat and poultry products to the United States. 

https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-ineligible-pork-products-imported-ecuador
FSIS Issues Public Health Alert for Ineligible Pork Products Imported From Ecuador
FSIS Announcement

WASHINGTON, Dec. 2, 2024 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert for frozen ready-to-eat pork mortadella products that may have been illegally imported from Ecuador, a country ineligible to export meat and poultry products to the United States. FSIS is continuing to investigate the origins of this product, and there may be additional products affected.

Georgia Facility Recalls Mustard Greens After State Lab Testing Finds Listeria

Baker Farms, Norman Park, GA, is recalling their Baker Farms Curly Mustard, 16 oz. plastic bags with BEST BY 11-21-2024, UPC: 8 13098 02018 4, Lot Code: bak144-6806 due to contamination of Listeria monocytogenes.  On 11-29-2024 the firm was notified by the Texas Department of State Health Services that the product tested positive for Listeria monocytogenes. The product was packed on 11/4/2024 and distributed between 11/5/2024 – 11/9/2024. This product was packaged in clear plastic bags and sold to distribution centers located in the states of: AL, AR, FL, GA, KY, LA, MS, TN & TX.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/baker-farms-recalls-baker-brand-curly-mustard-due-listeria-monocytogenes-contamination
Baker Farms Recalls Baker Brand Curly Mustard Due to Listeria Monocytogenes Contamination
Summary
Company Announcement Date: December 02, 2024
FDA Publish Date:  December 02, 2024
Product Type:  Food & Beverages  Produce  
Reason for Announcement:  Potential Foodborne Illness – Listeria monocytogenes
Company Name:  Baker Farms
Brand Name:  Baker Farms
Product Description:  Curly Mustard Greens

Producer of Raw Pet Food Issues Product Recall Due to Salmonella..Again

Blue Ridge Beef of Statesville, NC is recalling 9,60lb of their 2 lb log Puppy Mix Lot #08/06/N25 & 08/16/N25 UPC 854298001696 due to a contamination of Salmonella.  The problem was discovered when a customers litter of puppies became ill and reported the issue to VDACS.  On 11/27/24 the firm was notified by the FDA that these products tested positive for Salmonella.

Blue Ridge Beef has issued previous recalls for Salmonella contamination.  In December of 2023, a state lab found Salmonella / Listeria in the product for which the company issued a recall (which was expanded in Jan of 2024).  The company issued a recall in October of 2023 after the dog food tested positive for Salmonella.  There was also a recall in 2018.

Summary

Company Announcement Date:  December 02, 2024

FDA Publish Date:  December 04, 2024

Product Type: Animal & Veterinary Pet Food

Reason for Announcement: Potential Foodborne Illness - Salmonella

Company Name: Blue Ridge Beef

Brand Name: Blue Ridge Beef

Product Description: Puppy Mix

Company Announcement

STATESVILLE, NC – December 2, 2024 – Blue Ridge Beef is recalling 9,600 lbs. of their 2 lb log Puppy Mix Lot #08/06/N25 & 08/16/N25 UPC 854298001696 due to a contamination of Salmonella. (Lot numbers are stamped in the clips on the end of the chubs/bags)