Friday, August 30, 2024

FDA Issues Warning Letter to Small Sprout Operation

FDA issued a Warning Letter to a small sprout farm operation located in Pennsylvania.  The facility operates as a qualified facility under modified requirements.  However, FDA does tell the facility that the application of modified requirements can be removed by the FDA is warranted, then it would be subject to all relevant requirements in the Produce Safety Rule

Issues noted in the Warning Letter:
  • FDA investigators observed gray sludge falling from the railing where the automatic sprinkler system is mounted and accumulating in sprouts growing below. The company told our investigator that this gray sludge was food-grade oil. However, the company was not able to provide FDA investigators the container or labeling of the apparent oil. Further, the substance appeared dirty.  Further, during the inspection closeout meeting, the company stated that the sprouts that may have become contaminated would be discarded, however, the company had introduced into commerce the sprouts observed on that date. In addition, the company did not address how to prevent the contamination of in-process sprouts in the future.
  • FDA observed apparent rodent excreta pellets underneath a table in the packaging room, where packaging material used for ready to eat (RTE) mung bean sprouts was being stored.  This finding demonstrates that rodents have access to food contact surfaces and may have directly or indirectly contaminated the sprouts with feces. The third-party pest control company documented rodent activity on November 28, 2023, December 26, 2023, and January 23, 2024, and recommended actions to prevent recurrence, however, the company did not implement any of these recommended actions.
  • Facility issues included a) The ceiling in the sprout processing area has peeling and chipped paint, and apparent cobwebs and insect frass directly above the open sprout harvesting machine. b) The floor directly under the sprout harvesting machine in the sprout processing area was wet, pitted, and cracked. This may cause the floor to be a harborage site for pathogens.
  • On January 31, 2024, and February 1, 2024, FDA investigators observed a pressurized hose used to rinse food contact surface equipment and in-process sprouts frayed and stored on the floor in the sprout production room. This may have resulted in the contamination of your sprouts with any substances, including any pathogens, from the floor.  Furthermore, the hose described above was used without being cleaned or sanitized. An employee with gloved hands touched the circuit breaker, cleaned a seed bed, handled the hose, and then returned to handling sprouts without either changing their gloves or removing the gloves and handling the sprouts with clean hands. This may have resulted in the gloves contaminating the sprouts with any substances contacting the gloves prior to hose handling.
  • During the inspection, we observed that an exit door is in poor repair and unable to fully close to exclude pests from entering the facility. Additionally, there were harborage conditions around the perimeter of the facility that potentially attract pests, including sprouts around the external cement block of the unplugged trash receptacle and empty plastic containers behind the building.

WARNING LETTER
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pl-bean-sprout-farm-680777-07312024

P&L Bean Sprout Farm
MARCS-CMS 680777 — July 31, 2024

NY Firm Recalls Dough Based Products for Undeclared Wheat

M&P Food Production Ltd. of Brooklyn, NY is recalling multiple flavors of blintzes, pirozhki, and vareniki, because it may contain undeclared wheat, milk, and/or sesame.  The recall was initiated during an FDA inspection where it was discovered that the products containing wheat, milk, and/or sesame were distributed in packaging that did not reveal the presence of the specific allergens.

The company obviously did not know allergen labeling regulations.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mp-food-production-issues-allergy-alert-undeclared-wheat-and-milk-vareniki-pirozhki-and-blintzes
M&P Food Production Issues Allergy Alert on Undeclared Wheat and Milk in Vareniki, Pirozhki, and Blintzes
Summary
Company Announcement Date:  August 29, 2024
FDA Publish Date:  August 29, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared wheat and milk
Company Name:  M&P Food Productio. Ltd.
Brand Name:  M&P Food Productio. Ltd.
Product Description:  Blintzes, pirozhki, and vareniki

NJ Firm Recalls Raisins for Undeclared Sulfites

Sunco & Frenchie LLC of Pine Brook, New Jersey is recalling its 10oz Terrafina Golden Raisins because they may contain undeclared sulfites.  The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by Food Laboratory revealed that the sulfite containing product was distributed in packages that did not reveal the presence of sulfites.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sunco-frenchie-issues-allergy-alert-undeclared-sulfites-golden-raisins
Sunco & Frenchie Issues an Allergy Alert on Undeclared Sulfites in Golden Raisins
Summary
Company Announcement Date:  August 26, 2024
FDA Publish Date:  August 26, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Allergen-Undeclared Sulfites
Company Name:  Sunco & Frenchie LLC
Brand Name:  terrafina
Product Description:  Golden Raisins

Monday, August 26, 2024

Imported Murukku Product Recalled for Improperly Identified Allergens

Sri Lakshmi Narasimhar Overseas LLC of Edison, New Jersey is recalling the following products because Bliss Tree Butter Snacks may contain undeclared milk and/or sesame seeds. The presence of undeclared milk and/or sesame were discovered during the FDA review of the product labels.

The primary issue was the non-identification of milk in the form of butter.

According to Wikipedia,  "Muṟukku is a savoury, crunchy snack originating from the Indian subcontinent. The name muṟukku "twisting" refers to its shape. In India, murukku is especially common in the states of Andhra Pradesh, Odisha, Tamil Nadu, Karnataka, and Kerala. It is called murkulu or janthukulu in Andhra Pradesh."


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sri-lakshmi-narasimhar-overseas-llc-issues-allergy-alert-undeclared-milk-and-sesame-seeds-bliss-tree
Sri Lakshmi Narasimhar Overseas LLC Issues an Allergy Alert on Undeclared Milk and Sesame Seeds in Bliss Tree Butter Snacks
Summary
Company Announcement Date:  August 23, 2024
FDA Publish Date:  August 23, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Allergen-Undeclared milk, sesame
Company Name:  Sri Lakshmi Narasimhar Overseas LLC
Brand Name:  Bliss Tree
Product Description:  Butter Snacks

Canadian Firm Recalls Fudge Product After Packages Found to Have Mold Growth

Authentik Fudge of Sainte-Julie, Quebec, Canada, is recalling 840 units of Chocolate Fudge with Nuts branded MONTREAL FUDGE, due to potential mold growth contamination.  The company initiated this recall after a consumer complained about some mold pieces inside the purchased box and also found also some remaining unpacked sealed products at the manufactured place that had beginning signs of mold.

Fudge generally has a low water activity level.  If higher, than preservatives can be added.  So if a product does mold where it normally does not, then it may have been mis-formulated.  Another possibility is that the product could have been exposed to excessive moisture from the environment where that moisture condensed on the product surface. 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/authentik-fudge-recalls-fudge-nuts-because-potential-mold-growth
Authentik Fudge Recalls Fudge with Nuts Because of Potential Mold Growth
Summary
Company Announcement Date:  August 21, 2024
FDA Publish Date:  August 22, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Potential mold growth contamination
Company Name:  Authentik Fudge
Brand Name: Montreal Fudge
Product Description:  Chocolate Fudge with Nuts

NJ Firm Recalls Cinnamon Due to Elevated Lead Levels in Product

Gutierrez Distributor of Passaic, NJ is recalling El Servidor Corp and Gutierrez brand ground cinnamon because it has the potential to be contaminated with elevated levels of lead.  This recall, issued on August 23 expands recall issued on August 19, 2024.  The recall was the result of a sample analysis conducted by New York State Department of Agriculture and Markets (NYSAGM) that revealed the product contained elevated levels of lead. The Company has ceased the production and distribution of the product as FDA and the company continues their investigation as to what caused the problem.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gutierrez-distributor-expands-recall-ground-cinnamon-because-possible-health-risk
Gutierrez Distributor Expands Recall of Ground Cinnamon Because of Possible Health Risk
Summary
Company Announcement Date:  August 23, 2024
FDA Publish Date:  August 23, 2024
Product Type:  Food & Beverages  Spices, Flavors & Salts
Reason for Announcement:  Elevated lead
Company Name:  Gutierrez Distributors, LLC
Brand Name:  El Servidor Corp
Product Description:  Ground cinnamon

Popsicles Recalled for Undeclared Milk After Two Reports of Allergic Reaction

Unilever in the United States is recalling approximately 137,000 cases of Popsicle Jolly Rancher Frozen Confection Pop products (single serve offerings) because the products may contain milk, which is not listed as an ingredient on the label.

This recall has been initiated as a result of findings which indicate there may be a presence of milk allergens in the product which is not disclosed on the packaging. There have been two reported allergic reactions in connection with the use of this product

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/unilever-us-issues-allergy-alert-undeclared-milk-popsicle-jolly-rancher-singleserve-frozen
Unilever U.S. Issues Allergy Alert on Undeclared Milk in Popsicle Jolly Rancher SingleServe Frozen Confection Pops
Summary
Company Announcement Date:  August 21, 2024
FDA Publish Date:  August 21, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared milk
Company Name:  Unilever US
Brand Name:  Popsicle
Product Description:  Jolly Rancher Green Apple, Blue Raspberry, Grape Frozen Confection Pop

Nut Processor Recalls Walnut Product for Containing Other Nuts Due to Mislabeling

Flagstone Foods, LLC., manufacturer of Emerald Nuts, is issuing a voluntary recall of 6.5oz Emerald Kettle Glazed Walnut lot 2EE06284 because packages contain undeclared Peanuts, Almonds and Pecans.  This recall was initiated after consumers reported finding peanuts, almonds and pecans within packages labelled Emerald Kettle Glazed Walnuts. An investigation identified a limited number of incorrectly labelled packages were produced during the manufacturing process.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/flagstone-foods-llc-allergy-alert-undeclared-peanuts-almonds-and-pecan-emerald-kettle-glazed-walnuts
Flagstone Foods, LLC. Allergy Alert on Undeclared Peanuts, Almonds and Pecan in Emerald Kettle Glazed Walnuts
Summary
Company Announcement Date:  August 16, 2024
FDA Publish Date:  August 20, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared peanuts, almonds, pecans
Company Name:  Flagstone Foods, LLC
Brand Name:  Emerald
Product Description:  Emerald Kettle Glazed Walnuts

Monday, August 19, 2024

Georgia Establishment Recalls RTE Chicken Nuggets After Two Complaints for Metal Contamination

Perdue Foods LLC, a Perry, Ga. establishment, is recalling approximately 167,171 pounds of frozen, ready-to-eat chicken breast nugget and tender products that may be contaminated with foreign material, specifically metal.  The frozen, ready-to-eat chicken breast nugget and tender items were produced on March 23, 2024.  The problem was discovered after the firm received consumer complaints about metal wire embedded in the product and notified FSIS of the issue.  There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

https://www.fsis.usda.gov/recalls-alerts/perdue-foods-llc-recalls-frozen-ready-eat-chicken-breast-nugget-and-tender-products
Perdue Foods LLC, Recalls Frozen, Ready-To-Eat Chicken Breast Nugget and Tender Products Due to Possible Foreign Matter Contamination

Perdue Foods LLC

FSIS Announcement

WASHINGTON, Aug. 16, 2024 – Perdue Foods LLC, a Perry, Ga. establishment, is recalling approximately 167,171 pounds of frozen, ready-to-eat chicken breast nugget and tender products that may be contaminated with foreign material, specifically metal, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.