Wednesday, November 22, 2023

FDA Issues Warning Letter to Noodle Company

FDA issued a Warning Letter to Wan-Gee Foods of St. Louis MO. The company manufacturers not-ready-to-eat noodle products (i.e., wonton wrappers, egg roll wrappers, and noodles) .

Hazard Analysis and Preventive Controls
  • Did not identify Staphylococcus aureus as a hazard of concern which can be an issue if noodle dough is temperature abused.
  • "Did not identify and evaluate the hazard of bacterial growth and/or toxin formation {of Staphylococcus aureus] due to lack of time/temperature control as a known or reasonably foreseeable hazard to determine whether it requires a preventive control for your canton noodles during finished product storage. The canton noodles are treated as shelf stable, stored at ambient temperatures, and are not labeled to be kept refrigerated or frozen. You do not know the water activity of the finished product canton noodles, including whether it is above 0.85."
  • "did not identify and evaluate the hazard of mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control for your noodle products. The noodles contain wheat flour, which has been associated with mycotoxins such as deoxynivalenol (DON). Therefore, contamination with mycotoxins is a known or reasonably foreseeable hazard to be considered for these products."
  • "did not implement your preventive controls procedures to significantly minimize or prevent contamination with the hazard of metal in your nRTE noodle products. Our investigators observed damage and missing pieces to your metal cutting blades used to shorten the dried noodles after the drying room step. The investigators requested monitoring records associated with the metal detector, but you did not provide them during the inspection."
  • "written allergen preventive control does not include procedures, practices, and processes employed for labeling to ensure that all food allergens required to be stated are included on the label for your nRTE noodle products"  "procedure does not ensure all finished product labels declare all allergens present in the finished food to ensure finished food is not misbranded under section 403(w) of the Act (21 CFR 117.135(c)(2) because you do not document your review of finished product labels to ensure all allergens are properly declared."
  • "do not maintain any monitoring or corrective action records of your review of your product labels to ensure the allergen ingredients are listed on the label for each batch produced. The only record you maintain for production is your mixing log and it does not include are view of the allergen ingredients in the finished food against the packaging label."
GMPs
  • Black mold - "Apparent black mold formed on the ceiling directly over a drying canton noodle product in several locations throughout the room. The apparent mold covered approximately 30 percent of the ceiling. Further, the fans used to blow heated air ((b)(4) degrees Fahrenheit) directly onto the product to dry it were covered in approximately ¼ inch of apparent filth. In addition, the concrete floor along the walls in multiple locations throughout the drying room had what appeared to be white and greenish colored mold. The walls had apparent black mold in several different locations throughout the drying room."
  • Product on floor - "Employee hanging noodles on racks (b)(4). During our inspection, our investigators observed the two bins separate, causing an approximate 2-to-3-in. gap in between. This resulted in the bottom quarter of the noodles coming into contact with the floor."
  • Condensation - "heavily beaded condensation formed over and falling onto boxed wonton wrappers, lot number 05021168, in the blast storage freezer. Our investigators also observed condensation falling onto packaged finished product. Although the product is wrapped in wax paper, the packaging is made of thin cardboard that is not sealed and the product is susceptible to contamination while it is held overnight in the blast freezer. Our investigators observed ice formed in several other locations in the freezer, including the floor, freezer units, and walls."
  • Facility issues / potential foreign objects - "brittle plastic in several areas on the tray was broken and/or frayed. (b)(4) trays being used in production were in similar condition.. Foam was present on the underside of the (b)(4) that comes indirect contact with the top layer of the wrappers during cutting. The foam is porous and not easily cleanable. Our investigators observed deteriorating foam on (b)(4) blade presses ((b)(4) egg roll and (b)(4) wonton), and parts of the foam were missing in several areas around the edges."
  • Personal hygiene issues - did not take reasonable measures and precautions to ensure all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices while on duty to the extent necessary to protect again contamination of food, as required by 21 CFR 117.10(b). Specifically, on May 2, 2023, five out of ten employees were observed in street clothes covered in apparent filth while handling dough used to manufacture wonton wrappers
Wan-Gee Foods, Inc.
MARCS-CMS 660360 — NOVEMBER 09, 2023
Recipient:
Samson Wang
CEO/President
Wan-Gee Foods, Inc.
10849 Midwest Industrial Blvd.
St. Louis, MO 63132
United States

Monday, November 20, 2023

USDA Issues Public Health Alert for TX Establishment's Jerky Products for Undeclared Soy

USDA-FSIS issued a public health alert for meat and poultry jerky products produced by PRUSKI'S MARKET, INC. of Adkins, TX due to misbranding and undeclared allergen, soy, which is not declared on the product label.  A recall was not requested because the product is no longer available for purchase.  The problem was discovered by FSIS inspection personnel during a verification task where they discovered that soy was not included on the label.

https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-meat-and-poultry-jerky-products-due-misbranding-and
FSIS Issues Public Health Alert for Meat and Poultry Jerky Products Due to Misbranding and Undeclared Allergen

Illinois Establishment Recalls Ground Beef Due to Complaint for Foreign Material

Skyline Provisions, Inc., a Harvey, Ill. establishment, is recalling approximately 5,620 pounds of raw ground beef products that may be contaminated with a foreign object.  The problem was discovered after FSIS received a customer complaint reporting that a foreign object was found during food preparation.

No word on identity of the foreign object.  And it seems that it was one complaint that triggered the recall.


https://www.fsis.usda.gov/recalls-alerts/skyline-provisions-inc--recalls-raw-ground-beef-products-due-possible-foreign-matter
Skyline Provisions, Inc. Recalls Raw Ground Beef Products Due to Possible Foreign Matter Contamination

SKYLINE PROVISIONS

FSIS Announcement

WASHINGTON, Nov. 19, 2023 – Skyline Provisions, Inc., a Harvey, Ill. establishment, is recalling approximately 5,620 pounds of raw ground beef products that may be contaminated with a foreign object, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

FTC Cracks Down on Non-disclousre by Influencers on Social Media Discussing Nutrition Claims

Influencers, appearing on popular social media sites such as Instagram and TikTok. have become a important source of information for too many Americans (unfortunately).  FTC is beginning to crack down on paid endorsements where disclosures are not made, in this case, where industry associations paid for endorsements by influencers where disclosure of that payment was not made known by those influencers.

“It’s irresponsible for any trade group to hire influencers to tout its members’ products and fail to ensure that the influencers come clean about that relationship,” said Samuel Levine, Director of the FTC’s Bureau of Consumer Protection. “That’s certainly true for health and safety claims about sugar and aspartame, especially when made by registered dieticians and others upon whom people rely for advice about what to eat and drink.”

https://www.ftc.gov/news-events/news/press-releases/2023/11/ftc-warns-two-trade-associations-dozen-influencers-about-social-media-posts-promoting-consumption
FTC Warns Two Trade Associations and a Dozen Influencers About Social Media Posts Promoting Consumption of Aspartame or Sugar
Letters say influencers failed to adequately disclose that they were paid by industry
November 15, 2023

CDC Report on Salmonella Outbreak Associated with Cantaloupes

CDC is reporting on illness associated with contaminated cantaloupes that as of "November 17, 43 people infected with the outbreak strain of Salmonella have been reported from 15 states . Illnesses started on dates ranging from October 17, 2023, to November 6, 2023 (see timeline). Of 30 people with information available, 17 have been hospitalized. No deaths have been reported."

Posted November 17, 2023
Fast Facts
Illnesses: 43
Hospitalizations: 17
Deaths: 0
States: 15
Recall: Yes
Investigation status: Active



Sunday, November 19, 2023

VT Ice Cream Company Recalls All Products After State Lab Finds Listeria Positive Sample

Wilcox Ice Cream of East Arlington, VT is recalling all flavors of Wilcox brand ice cream, yogurt, and ice cream bars, as well as Leonardo’s brand gelato after being notified by the Vermont Department of Agriculture on 11/14/23 that one lot of the Super Premium Mint Chip manufactured that day may be contaminated with Listeria monocytogenes.  The company stated in the report, "We were notified by the Vermont Department of Agriculture, who was notified by the New Hampshire Department of Health on 11/14/23 that a routine sample collected by that agency of our Super Premium Mint Chocolate Chip manufactured on 9/15/23 tested positive for Listeria monocytogenes. As part of our investigation, we determined that preliminary testing showed that the ice cream mix purchased to make our products may contain Listeria monocytogenes."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wilcox-ice-cream-recalls-multiple-ice-cream-products-because-possible-health-risk
Wilcox Ice Cream Recalls Multiple Ice Cream Products Because of Possible Health Risk
Summary
Company Announcement Date:  November 18, 2023
FDA Publish Date:  November 18, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Potential to be contaminated with Listeria monocytogenes
Company Name:  Wilcox Ice Cream
Brand Name:  Multiple brands
Product Description:  Ice Cream, Yogurt, Ice Cream Bars and Gelato in a Variety of Flavors

Stone Fruit Recalled After Linked to Listeria Outbreak with 11 cases

The HMC Group Marketing, Inc., based in Kinsburg, CA, which does business as HMC Farms, is voluntarily recalling peaches, plums and nectarines sold in retail stores between May 1 and November 15, 2022 and between May 1 and November 15, 2023. The fruit is being recalled because it has the potential to be contaminated with Listeria monocytogenes.  The recalled peaches have been linked to an outbreak of Listeriosis that has resulted in eleven illnesses.  There has been one reported death.
The age range  is from 30 to 80 years    Median age of 69    73% are 65 years or older

The source of Listeria in these cases is likely to be the facility in which the product is packed.  Product in these packages will often be washed and dried prior to filling in the bag.  These washing / drying systems are areas where investigators will likely focus sampling.



https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hmc-farms-voluntarily-recalls-whole-peaches-plums-and-nectarines-sold-retail-stores-2022-and-2023
HMC Farms Voluntarily Recalls Whole Peaches, Plums and Nectarines Sold at Retail Stores in 2022 and 2023 Because of Possible Health Risk
Summary
Company Announcement Date:  November 17, 2023
FDA Publish Date:  November 17, 2023
Product Type:  Food & Beverages  Fruit/Fruit Product
Reason for Announcement:  Potential to be contaminated with Listeria monocytogenes
Company Name:  The HMC Group Marketing, Inc.
Brand Name:  Multiple brands
Product Description:  Whole Peaches, Plums, and Nectarines

MA Seafood Company Recalls Salmon Burgers for Undeclared Sesame and Milk

Raw SeaFoods, Inc. of Fall River, MA is recalling Farm Raised Lightly Seasoned Atlantic Salmon Burgers due to undeclared sesame and milk allergens.   The recalled product was sold in the seafood department of Whole Foods Market stores nationwide from August 25, 2023 through November 15, 2023.  The problem was discovered after a vendor reported visible sesame seeds present on the product. An investigation is currently under way to discover the cause. No illnesses have been reported to date.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/raw-seafoods-inc-issues-allergy-alert-undeclared-sesame-and-milk-farm-raised-lightly-seasoned
Raw SeaFoods, Inc. Issues Allergy Alert for Undeclared Sesame and Milk in Farm Raised Lightly Seasoned Atlantic Salmon Burgers
Summary
Company Announcement Date:  November 16, 2023
FDA Publish Date:  November 16, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Sesame and Milk
Company Name:  Raw SeaFoods, Inc.
Brand Name:  Raw SeaFoods
Product Description:  Farm Raised Lightly Seasoned Atlantic Salmon Burgers

TX Pet Food Manufacturer Expands Recall to All Products Due to Salmonella

TFP Nutrition is expanding their voluntary recall that was initiated to include all dry dog, dry cat, and catfish formulas manufactured in their Nacogdoches, Texas, facility. The recall of these production codes is being conducted due to the potential for Salmonella contamination.  The recall, initially posted on October 30, 2023 and then expanded on November 13, 2023.

As indicated earlier, expansions of these recalls can occur when it is determined that the facility could not demonstrate that they had control of the pathogen over time.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tfp-nutrition-expands-voluntary-recall-dry-dog-dry-cat-and-catfish-food-due-potential-salmonella
TFP Nutrition Expands Voluntary Recall of Dry Dog, Dry Cat, and Catfish Food Due to Potential Salmonella Health Risk. Recall Includes Dry Dog, Dry Cat, and Catfish Foods Manufactured in Nacogdoches, TX Facility
Summary
Company Announcement Date:  November 16, 2023
FDA Publish Date:  November 16, 2023
Product Type:  Animal & Veterinary  Food & Beverages  Pet Food
Reason for Announcement:   Potential Salmonella contamination
Company Name:  TFP Nutrition
Brand Name:  Multiple brands
Product Description:  Dry Dog, Dry Cat, and Catfish Food