FDA Issues Warning Letter to Texas Pet Food Company for Inability to Combat Salmonella Contamination

FDA issued a Warning Letter to Mid America Pet Food LLC, a pet food manufacturing facility located in Mount Pleasant, Texas.  This was a reinspection of the facility that was responsible for a 2023 outbreak of Salmonella after a product recall had been issued.  (Initially Salmonella was found in product.  A multi-state foodborne illness outbreak of Salmonella Kiambu implicated in human illnesses through epidemiological traceback.1 A total of seven people from seven states were infected with the outbreak strain from January 14, 2023 to August 19, 2023, and one person was hospitalized. Six of the affected people were children under one year of age).  

"FDA collected environmental samples (i.e., swabs) from surfaces in [the] manufacturing facility during this inspection and a subsequent inspection, conducted from January 23, 2024, through February 9, 2024, in response to a consumer complaint. Analysis of these samples using whole genome sequencing revealed that three of the Salmonella-positive environmental swabs collected in the post-process area of [the] facility during the 2024 inspection are closely related to seven Salmonella-positive environmental swabs collected in the pre-process areas of your facility during the 2023 inspection, indicating that [the] facility may have three resident strains of Salmonella: Salmonella Rissen, Salmonella Minnesota, and Salmonella Mbandaka."

• FDA Investigators observed visible debris on food-contact surfaces of equipment such as brushes, brooms, and squeegees after cleaning and sanitizing of equipment was performed by your third-party sanitation service.
• Did not document (b)(4) cleaning for the discharge hoppers located in the packaging area for the entire month of December 2023.  In addition, there were multiple instances of other equipment and areas where [employees] did not document sanitation activities in accordance with your Master Cleaning Schedule
•  FDA Investigators observed rainwater entering your facility through the roof while  manufacturing multiple lots of dog food. FDA Investigators observed standing water and soaked absorbent pads in staging, production, and finished product areas, including in post-process areas such as the dryer room and packaging areas. The manufacturing facility must be constructed in a manner such does not become a source of potential contamination to your animal food.
• Did not document the (b)(4) process control applied to the chicken fat prior to January 13, 2024, which demonstrates the company did not effectively implement your process control.
• Did not take appropriate corrective action when a preventive control, combination of preventive controls, or the food safety plan as a whole was found to be ineffective, specifically in handling situations were positive samples were detected.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mid-america-pet-food-llc-681516-11222024
WARNING LETTER
Mid America Pet Food LLC
MARCS-CMS 681516 — November 22, 2024

Michigan Bakery Cited by FDA for Issues with Food Safety Plan and Its Implementation

FDA issued a Warning Letter to Knickerbocker 365 Inc, a processor of ready-to-eat (RTE) breads, rolls, and buns manufacturing facility located in Madison Heights, MI.

This points out many of the same issues identified in bakery operations.

The hazard analysis did not identify and evaluate a known or reasonably foreseeable hazard to determine whether it requires a preventive control.  

• The company did not consider recontamination with environmental pathogens, such as Salmonella, at steps where your RTE breads, rolls, and buns are exposed to the environment. The RTE breads, rolls, and buns are exposed to the environment at post-baking steps (including “Cooling,” “De-panning,” “Slicing,” and “Packaging”) where they could be contaminated with environmental pathogens such as Salmonella, and do not receive a lethal treatment or otherwise include a control measure (such as formulation lethal to the pathogen) that would significantly minimize pathogens.
• The RTE breads, rolls, and buns come into direct contact with post-baking equipment, such as the “(b)(4) slicer” “the (b)(4) Slicer,” and the “(b)(4) Slicer.” However, The FDA noted that written sanitation procedures, documented on the “(b)(4) Cleaning Checklist,” for equipment used post-baking do not indicate sanitizer concentration or how to clean utensils and clean out-of-place (COP) equipment (e.g., pieces of equipment (i.e., blades) from the (b)(4) slicing machine) that are cleaned and sanitized in the (b)(4) sink.
• In addition, the  facility’s environmental testing document is not clear on the frequency of collecting environmental samples for pathogens, including Salmonella. In the “Purpose” section, the document states that “Testing is to occur at the (b)(4) procedures at (b)(4).” However, in the “Background” section, the document indicates that (b)(4) for “Salmonella sp.” will be “collected quarterly.” The “Limit and Testing occurrences” in the “Procedures” section notes testing for Salmonella “at least annually.” Furthermore, the procedure does not indicate the analytical method that will be used.
• The company did not identify and implement a supply-chain preventive control to ensure control of ingredient-related pathogens.The hazard analysis for RTE breads, rolls, and buns, “21.0 HACCP Last Revision 3/2024,” identified at receiving steps for wheat flour, whey (b)(4), egg, and walnut ingredients, pathogens as a hazard associated with these ingredients used in your RTE products. The hazard analysis further identified a supply-chain control to control the pathogen hazard. However, The company did not have a written supply-chain program covering the pathogen hazard in the referenced ingredient.
• The written allergen preventive control did not include procedures, practices, and processes for ensuring protection of food from allergen cross-contact, including during storage, handling, and use, and for food labeling to ensure the food is not misbranded

The food safety plan was not prepared, nor was its preparation overseen, by one or more preventive controls qualified individual(s), as required by 21 CFR 117.126(a)(2). The hazard analysis indicates that it was approved by the President/Owner (Sandra Sokana) who is not a PCQI, and there is no PCQI trained individuals or individuals who are qualified through experience to develop and apply a food safety system.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/knickerbocker-365-inc-687624-09302024
WARNING LETTER
Knickerbocker 365 Inc.
MARCS-CMS 687624 — September 30, 2024

Additional Products Recalled After Linked to Cucumber Recall for Salmonella

Four companies are issuing recalls for cucumbers and cucumber products that after it was determined that the cucumbers they used are included in the recalled cucumbers which had been linked to the  Salmonella outbreak.

• Select lots of Gyro Family Kits were recalled from Sprouts stores on 12/06/2024 after being alerted by their supplier Reser’s Fine Foods, Inc. of potential Salmonella contamination of the cucumbers within the tzatziki sauce.
• Dairyland Produce, LLC, dba Hardie’s Fresh Foods of Houston, TX and Dallas, TX are recalling CUCUMBER SELECT 6 CT, because it has the potential to be contaminated with Salmonella
• F&S Fresh Foods, Riverside, CA is recalling Mediterranean Inspired Party Tray 22 oz. The recall was initiated after F&S Fresh Foods was notified that Grecian Delight Tzatziki sauce supplied to F&S Fresh Foods may be contaminated with Salmonella
• Baloian Farms of Arizona Co. (Baloian) has initiated a recall of cucumbers due to possible health risks due to salmonella. As a result, Fresh Creative Foods is voluntarily recalling one product that contains cucumbers in the tzatziki sauce included in the kit.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/resers-fine-foods-inc-recalls-select-lots-sprouts-farmers-market-gyro-family-kits-due-potential
Reser’s Fine Foods, Inc. Recalls Select Lots of Sprouts Farmers Market Gyro Family Kits Due to Potential Salmonella Contamination

Summary

Company Announcement Date:  December 09, 2024

FDA Publish Date:  December 10, 2024

Product Type:  Food & Beverages

Reason for Announcement:  Potential Foodborne Illness - Salmonella

Company Name:  Reser’s Fine Foods, Inc

Brand Name:  Sprouts Farmers Market

Product Description:  Gyro Family Kit

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