Warning Letter Issued to Hawaii Water Processor

FDA inspected a bottled water manufacturing facility located in Hilo, HI and issued a Warning Letter to that firm.  For one, the treatment of product water was not done in a manner that was effective in accomplishing the intended purpose.   In fact, the firm started receiving consumer complaints regarding foreign material including but not limited to apparent “mold”, “white blob”, and “floaters” in 1-liter bottles of its  Waiakea Hawaiian Volcanic Water.  A third-party laboratory found "heterotrophic plate count (HPC) at >5700 CFU/mL, Pseudomonas aruginosa at >2400 MPN/100mL, and mold at 15 CFU/mL."  Also, "the process controls did not include, as appropriate to the nature of the applicable control and its role in the facility's food safety system, parameters associated with the control of a hazard, as required by 21 CFR 117.135(c)(1)(i)"

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/waiakea-bottling-inc-681285-08132024
Waiakea Bottling Inc.
MARCS-CMS 681285 — August 13, 2024

Illinois Food Company Recalls Cinnamon Powder After State Lab Detects Lead

Asli Fine Foods of Woodridge, IL is recalling Asli Cinnamon Powder 7 oz, because it has the potential to be contaminated with Lead.  Product was distributed MN, IN, IL, MO & OH it reached consumers through retail stores.  The recall was the result of a routine sampling program by the Missouri Department of Health and Senior Services which revealed that the finished products contained Lead. The company has ceased the production and distribution of the product as FDA and the company continue their investigation as to what caused the problem.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/asli-fine-foods-recalls-asli-cinnamon-powder-7-oz-because-possible-health-risk
Asli Fine Foods . Recalls Asli Cinnamon Powder 7 oz Because of Possible Health Risk
Summary
Company Announcement Date:  August 29, 2024
FDA Publish Date:  August 30, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Contains Lead
Company Name:  Asli Fine Foods
Brand Name:  Asli Fine Foods
Product Description:  Cinnamon powder

CDC Provides Update on Listeria Outbreak Linked to Deli Meat

CDC provided an update of the Listeria outbreak linked to Boar's Head deli meat.  Since the last update on August 8, 14 more illnesses and six more deaths have been reported. As of August 27, a total of 57 people infected with the outbreak strain of Listeria have been reported from 18 states. S Of 57 people with information available, all 57 have been hospitalized.   There have been 9 deaths.

CDC Food safety alert
https://www.cdc.gov/listeria/outbreaks/delimeats-7-24.html
Listeria Outbreak Linked to Meats Sliced at Delis
August 28, 2024

Investigation start date: July 19, 2024
Investigation status: Open
Recall issued: Yes

Latest update: More illnesses and deaths have been reported in this outbreak. Listeria is a hardy germ that can remain on surfaces, like meat slicers, and foods, even at refrigerated temperatures. It can also take up to 10 weeks for some people to have symptoms of listeriosis. Do not eat recalled deli meats. Some of the products have sell by dates into October 2024.

Fast Facts
Cases: 57 (14 new)
Hospitalizations: 57 (14 new)
Deaths: 9 (6 new)
States: 18 (5 new)

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

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