Category Archives: FDA

USA- Research – Investigations of Foodborne Outbreaks and Adverse Events in FDA-Regulated Foods

FDA

CORE 2022 Activities
65 Incidents Evaluated:
Incidents evaluated includes potential outbreaks, confirmed outbreaks, and adverse
events that were evaluated by the CORE Signals and Surveillance Team. Not all
incidents evaluated by Signals are transferred to Response for follow up.
28 Responses Initiated:
When an outbreak appears to be caused by an FDA-regulated food, this information is
passed to a Response Team to coordinate FDA’s response efforts.
11 Advisories Issued:
Public health advisories are issued to provide consumers with actionable advice about
an FDA-regulated food linked to an outbreak.

USA – FDA – Enforcement Report – Potential C. botulinum growth and toxin formation

FDA

Event ID: 93557

Voluntary / Mandated:

Voluntary: Firm initiated

Product Type: Food

Status: Ongoing

Distribution Pattern:

U.S. Distribution to Supermarkets in CA, HI, WA, IL, NV, and TX. No foreign distribution.

Recalling Firm:Foremost Foods International, Inc.
2883 Surveyor St
Pomona, CA 91768-3251
United States

Press Release URL(s):

Recall Initiation Date:

12/1/2023

Center Classification Date:

1/4/2024

1
Pamana Premium Marinated Baby Bangus (Deboned Marinated Baby Milkfish), Net Weight to be Weight at Time of Sale

F-0691-2024

Class II
All product codes

432 boxes

Potential C. botulinum growth and toxin formation. Frozen bangus (milkfish) in reduced oxygen packaging does not contain instructions to keep frozen and instructions for proper thawing (e.g., “Important, keep frozen until used, thaw under refrigeration immediately before use.”).

2
Pamana Premium Marinated Bangus (Deboned Marinated Milkfish), Net Weight to be Weight at Time of Sale

F-0692-2024

Class II
All product codes

407 boxes

Potential C. botulinum growth and toxin formation. Frozen bangus (milkfish) in reduced oxygen packaging does not contain instructions to keep frozen and instructions for proper thawing (e.g., “Important, keep frozen until used, thaw under refrigeration immediately before use.”).

3
Pamana Premium Bangus Belly (Cut Deboned Milkfish Belly), 340 g (120 oz)

F-0693-2024

Class II
All product codes

448 boxes

Potential C. botulinum growth and toxin formation. Frozen bangus (milkfish) in reduced oxygen packaging does not contain instructions to keep frozen and instructions for proper thawing (e.g., “Important, keep frozen until used, thaw under refrigeration immediately before use.”).

Korea – Food Poisoning Bacteria Detected in Orion’s Custard Snack; FDA Halts Sales, Orders Recall

Business Korea

The Food and Drug Administration announced on Jan. 3 that it is currently suspending sales and recalling the Orion food company’s popular “Custard” snack after detecting food poisoning bacteria in the product. Custard is considered to be one of Orion’s signature products alongside Choco Pies.

According to the FDA, Staphylococcus aureus, the detected bacterium, secretes toxins in food, causing symptoms like vomiting and diarrhea. A “non-compliant” judgment is issued if even one of five samples tests positive for this bacterium during inspections.

The manufacturing date of the affected product is Dec. 22, 2023, with an expiration date of June 21, 2024. The product is a 276 g package containing 12 snacks weighing 23 g each. It was found that a total of 1,318.2 kg of this product had been shipped from Orion’s 4th Cheongju factory.

An Orion representative stated, “We immediately took recall measures upon receiving the results of our self-administered quality inspection. Most of the products targeted for recall have already been collected, and we plan to complete the recall by tomorrow.”

출처 : Businesskorea(https://www.businesskorea.co.kr)

USA – Investigations of Foodborne Illness Outbreaks

FDA

What’s New

  • For the outbreak of Salmonella Newport (ref# 1201) in a not yet identified food, the case count has increased from 44 to 45 cases.

USA – Expanded Recall Affected States: Blue Ridge Beef Issues Voluntary Recall of Blue Ridge Beef Kitten Grind, Blue Ridge Kitten Mix and Blue Ridge Beef Puppy Mix Due to Salmonella and Listeria Monocytogenes Contamination

FDA

A previous version of this press release was issued on 12/22/2023. This press release was updated to include all states that may have received the recalled product lot numbers.

STATESVILLE, NC – January 3, 2024 – Blue Ridge Beef is expanding their recall to include additional lot numbers. This recall includes all lot numbers and used by dates between N24 1114 to N24 1224 of their 2 lb log of Kitten Grind UPC 8 54298 00101 6; 2lb log of Kitten Mix UPC 8 54298 00143 6 and their 2lb log of Puppy Mix UPC 8 54298 00169 6 due to contamination of Salmonella and Listeria monocytogenesSalmonella and Listeria monocytogenes can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.

Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.

Pets with Salmonella and Listeria infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever, and abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.

On 12/15/2023 the firm was notified by the North Carolina Department of Agriculture and Consumer Services that one lot of each of the products were sampled and tested positive for Salmonella and Listeria monocytogenes. However, out of an abundance of caution the firm is recalling all lots with the used by dates between N24 1114 to N24 1224.

No illnesses have been reported to date.

The products were distributed between 11/14/2023 – 12/20/2023. These products were packaged in clear plastic and sold primarily in retail stores located in the states of: CT, FL, IA, IL, MA, MD, MI, NC, NY, OH, OR, PA, RI, TN, VA & WI. Image of the products are below.

Products affected are:

Product

Size

UPC

All Lot #/Use By Dates Between

Kitten Grind 2lbs 8 54298 00101 6 N24 1114 to N24 1224
Kitten Mix 2lbs 8 54298 00243 6 N24 1114 to N24 1224
Puppy Mix 2lbs 8 54298 00169 6 N24 1114 to N24 1224

The lot numbers and used by dates are located on the silver tabs at the end of the tubes.

Consumers who have purchased these products are urged to contact Blue Ridge Beef at blueridgebeefnc@yahoo.com for a full refund and destroy the food in a way that children, pets, and wildlife cannot access. Do not sell or donate the recalled products. Do not feed the recalled product to pets or any other animals. Wash and sanitize pet food bowls, cups, and storage containers. Always ensure you wash and sanitize your hands after handling recalled food or any utensils that come in contact with recalled food. Consumers with questions may contact Mr. Steven Lea at (704) 880-4500 Monday through Friday 8:00 am – 5:00 pm EST.

This recall is being made with the knowledge of the Food and Drug Administration.


Company Contact Information

Consumers:
Mr. Steven Lea
 704-880-4500

USA – FDA – US Gulf Coast Trading Co., Inc. – Warning Letter

FDA

The United States Food and Drug Administration (FDA) inspected your refrigerated, frozen, and ambient food product warehouse located at 14100 Auto Park Way Ste. I, Houston, TX on August 7 through 15, 2023. During our inspection, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule) in Title 21, Code of Regulations, Part 117 (21 CFR part 117). At the conclusion of the inspection, FDA issued a Form FDA 483, Inspectional Observations, listing deviations found at your firm. In addition, during the inspection, FDA collected filth samples from various areas within your warehouse facility, and the analytical results revealed rodent filth present throughout your facility.

Based on FDA’s inspectional findings, we have determined that the food products warehoused in your facility are adulterated within the meaning of section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(3)] because they consist in whole or in part of any filthy, putrid, or decomposed substance, or are otherwise unfit for food, and section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)] because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act and FDA regulations through links in FDA’s Internet home page at http://www.fda.gov.

USA- FDA Warning Letter- Lone Star Botanicals Inc.

FDA

The United States Food and Drug Administration (FDA) inspected your food manufacturing facility, located at 2001 Broussard St., Tyler TX 75701 on April 17-21, 2023. Your firm manufactures and repackages, among other food products, ready-to-eat (RTE) seasoning blends. During the inspection, the FDA investigator found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). At the conclusion of the inspection, FDA issued a Form FDA 483 (FDA- 483), Inspectional Observations, listing the deviations found at your firm. Based on FDA’s inspectional findings, we have determined that the ready-to-eat (RTE) seasoning products manufactured in your facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the Preventive Controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)]. Further, we found significant violations of the labeling regulations for foods, 21 CFR Part 101. These violations cause  your seasoning blends and Dr. Botanical Health products to be misbranded within the meaning of section 403 of the Act (21 U.S.C. § 343).

USA – FDA sends Cooperstown Cheese Company warning after inspection finds Listeria in facility

Food Safety News

A food firm in New York is on notice from the FDA  for serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation. These violations include the presence of Listeria monocytogenes, mold and more.

Last July, Cooperstown Cheese Company recalled 1,400 pounds of cheese because of positive tests for Listeria monocytogenes contamination.

In a Nov. 24, 2023, warning letter, the FDA described a June 21 through July 28, 2023 inspection of their ready-to-eat (RTE) raw milk cheese manufacturing facility in Milford, NY.

USA – FDA – Investigations of Foodborne Illness Outbreaks

FDA

Date
Posted
Ref Pathogen
or
Cause of
Illness
Product(s)
Linked to
Illnesses

(if any)
Total
Case
Count

Status
12/6/

2023

1205 Listeria
monocytogenes
Not Yet
Identified
3 Active
11/22/

2023

1201 Salmonella
Newport
Not Yet
Identified
44 Active
11/22/

2023

1203 Salmonella
Sundsvall and
Oranienburg
Cantaloupe See

Advisory

Active
11/15/

2023

989 Listeria
monocytogenes
Peaches, Plums,
and Nectarines
See

Advisory

Active
11/8/

2023

1198 Elevated Lead
Levels
Apple
Cinnamon
Puree
See

Advisory

Active

USA – Campylobacter illnesses in Utah prompt Canadian Oyster Recall

Food Poison Journal

The FDA has warned about certain oysters harvested in Canada and sold in the United States because two people have become infected with Campylobacter jejuni.

On Dec. 18, the Utah Shellfish Authority notified the Food and Drug Administration of two cases of Campylobacter connected to consumption of oysters from British Columbia, Canada. The FDA has notified the Canadian Food Inspection Agency (CFIA) of the illnesses, and the CFIA is investigating.  The two patients consumed oysters in Utah and Wisconsin, and the FDA is coordinating with the CFIA and state authorities to determine if any additional distribution occurred.

The FDA is awaiting further information from the CFIA on the distribution of the oysters and will continue to monitor the investigation and help state authorities as needed.

The FDA is advising restaurants and food retailers not to serve or sell and to dispose of oysters and consumers not to eat oysters from Pacific Oyster Fanny Bay, harvested on Nov. 8 from harvest area BC 14- 8 with Landfile # 1402294 and Oyster Malaspina Live, harvested on Nov. 9 from harvest area BC 14-8 with Landfile # 278761 and shipped to distributors in Utah and Wisconsin.