FDA Planning for Unannounced Inspections at Foreign Manufacturing Facilities

The US FDA announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, ensuring that foreign companies receive the same level of regulatory oversight and scrutiny as domestic companies.

"For too long, foreign companies have enjoyed a double standard—given advanced notice before facility inspections, while American manufacturers are held to rigorous standards with no such warning. That ends today. This is a key step for the FDA as part of a broader strategy to get foreign inspections back on track,” said FDA Commissioner Martin A. Makary, M.D, M.P.H.

"The FDA conducts approximately 12,000 domestic inspections and 3,000 foreign inspections each year in more than 90 countries. While U.S. manufacturers undergo frequent, unannounced inspections, foreign firms have often had weeks to prepare, undermining the integrity of the oversight process. Despite the advanced warning that foreign firms receive, the FDA still found serious deficiencies more than twice as often than during domestic inspections."

https://www.fda.gov/news-events/press-announcements/fda-announces-expanded-use-unannounced-inspections-foreign-manufacturing-facilities
FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities

For Immediate Release:
May 06, 2025

CDC Reports Salmonella Outbreak Linked to Backyard Chickens

As of April 24, a total of 7 people infected with the outbreak strain of Salmonella Mbandaka have been reported from 6 states. Illnesses started on dates ranging from February 9, 2025, to March 24, 2025.

Of 4 people with information available, 2 (50%) reported purchasing or obtaining poultry before getting sick. People reported obtaining poultry from agricultural retail stores. Investigators continue to collect information about where sick people obtained poultry and what hatcheries supplied the retail stores that ill people purchased poultry from.

This outbreak strain has been linked to two hatcheries in past outbreaks, including one which is also linked to the poultry shipping material sample in the current outbreak. 

https://www.cdc.gov/salmonella/outbreaks/mbandaka-05-01/index.html
Salmonella Outbreak Linked to Backyard Poultry
Key points

• Investigation status: Open
• Recall issued: No
• Public health officials are investigating a multistate outbreak of Salmonella illnesses linked to contact with backyard poultry. Any backyard poultry can carry Salmonella germs that can make you sick. Always take steps to stay healthy around your flock.

Fast Facts
Cases: 7
Hospitalizations: 0
Deaths: 0
States: 6

Two Distributors Recall Florida Grown Tomatoes Due to Potential Salmonella

Two produce distributors, one in Indiana and one in South Carolina, are recalling tomatoes due to the potential for Salmonella contamination. In both cases, tomatoes originate from farm grower in Immokalee. FL (Hanshaw Produce, Hanshaw and Capling Farms).


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ray-mascari-inc-recalls-4-count-vine-ripe-tomatoes-because-possible-health-risk
Ray & Mascari Inc. Recalls 4 Count Vine Ripe Tomatoes Because of Possible Health Risk
Summary
Company Announcement Date: May 02, 2025
FDA Publish Date:  May 03, 2025
Product Type:  Food & Beverages  Produce
Reason for Announcement:  Potential Foodborne Illness - Salmonella
Company Name:  Ray & Mascari Inc
Brand Name:  Ray & Mascari Inc.
Product Description:  Tomatoes

Imported Monkish Liver Recalled for Undeclared Milk

JJWV Marketing Corporation of Santa Fe Springs, California is recalling Ankimo Monkfish Liver because it may contain undeclared milk.  The recall was initiated after it was discovered that product containing the milk protein was in packaging that did not properly label the presence of milk.

Monkfish liver is a Japanese delicacy.  What does it taste like - according to one website, - "it is naturally creamy and smooth, sliding across the palate and melting in the mouth like butter. There is a slight and subtle natural sweetness, complementing the savory nature of this ingredient (think of the sweetness of lobster that no one would mistake for dessert)."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/food-co-issues-allergy-alert-undeclared-milk-monkfish-liver-ankimo
Food Co. Issues Allergy Alert on Undeclared Milk in Monkfish Liver - Ankimo
Summary
Company Announcement Date:  April 28, 2025
FDA Publish Date:  May 01, 2025
Product Type:  Food & Beverages
Reason for Announcement: Potential or Undeclared Allergen - Milk
Company Name:  JJWV Marketing Corporation
Brand Name:  Ankimo
Product Description:  Monkfish Liver

Case of Intention Adulteration - Disgruntled Employee from Chemical Company Hacks Into Chemical Cleaning System

In South Carolina, a disgruntled former employee of a chemical cleaning company is accused of hacking into a remote chemical cleaning system used by a South Carolina poultry plant, changing "he distribution, flow rates and solution levels throughout multiple stages of the poultry processing at the Sumter company, identified only as “Company P,” the indictment said."

The chemicals whose dosage the former  senior electronics customer service support employee manipulated were peracetic acid and sodium hydroxide, which are “hazardous chemicals that pose a health risk to humans, both in their under-application and over-application,” the indictment said.

Cybersecurity has become an important facet of a company's food defense plan.  In this case, we see the importance of remote access to chemical addition.

The State - CRIME & COURTS
https://www.thestate.com/news/local/crime/article305396216.html
‘Disgruntled’ man sabotaged SC chicken plant, threatened public health, feds say By John Monk Updated April 30, 2025 2:27 PM

NY Establishment Recalls Sausage and Sliced Meat Products for Excessive Sodium Nitrite Levels

Smith Packing, LLC, a Utica, N.Y. establishment, is recalling approximately 18,792 pounds of various ready-to-eat sausage and sliced meat and poultry products due to sodium nitrite levels that exceed the regulatory limit. The problem was discovered after the firm notified FSIS that it had received consumer complaints of products that were off-taste and off-color.

https://www.fsis.usda.gov/recalls-alerts/smith-packing-llc-recalls-sausage-and-sliced-meat-and-poultry-products-due-sodium
Smith Packing, LLC Recalls Sausage and Sliced Meat and Poultry Products Due to Sodium Nitrite Levels in Excess of Regulatory Limit

FSIS Announcement

WASHINGTON, April 29, 2025 – Smith Packing, LLC, a Utica, N.Y. establishment, is recalling approximately 18,792 pounds of various ready-to-eat sausage and sliced meat and poultry products due to sodium nitrite levels that exceed the regulatory limit, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

NJ Establishment Recalls Pork Bun Product for Undeclared Sesame

ACC Central Kitchen LCC., a Thorofare, N.J. establishment, is recalling approximately 64,008 pounds of pork bun products due to misbranding and undeclared allergens - the product contains sesame, a known allergen, which is not declared on the product label. .  The problem was discovered during routine FSIS in-plant verification activities when FSIS inspection personnel noticed that the sesame ingredient used in the pork buns was not declared on the product label.


https://www.fsis.usda.gov/recalls-alerts/acc-central-kitchen-llc-recalls-pork-bun-products-due-misbranding-and-undeclared
ACC Central Kitchen LLC Recalls Pork Bun Products Due To Misbranding and Undeclared Allergens

FSIS Announcement

WASHINGTON, April 24, 2025 – ACC Central Kitchen LCC., a Thorofare, N.J. establishment, is recalling approximately 64,008 pounds of pork bun products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains sesame, a known allergen, which is not declared on the product label.

Trader Joe's Salad Product Recalled for Undeclared Milk After Cheese Crumbles Packets Mistakenly Added Instead of Crispy Onion Packets

Taylor Fresh Foods Illinois is recalling a limited quantity of Trader Joe’s Sesame Miso Salad with Salmon because the topping packet may potentially contain an undeclared milk allergen.  The product may contain milk that is not declared on the label. 500 units of the salad were mistakenly packaged with a sealed packet of parmesan cheese crumbles (instead of a packet of crispy onions).

A number of recalls such as this have occurred when the incorrect packet is added to the product.  We discuss the importance of having preventive controls for labeling, but consideration must be given to ensuring the proper addition of these packets into kit-type packs.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/trader-joes-sesame-miso-salad-salmon-voluntarily-recalled-due-undeclared-milk-allergen
Trader Joe’s Sesame Miso Salad with Salmon Voluntarily Recalled Due to Undeclared Milk Allergen
Summary
Company Announcement Date:  April 28, 2025
FDA Publish Date:  April 29, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Potential or Undeclared Allergen - Milk
Company Name:  Taylor Fresh Foods
Brand Name:  Trader Joe’s
Product Description:  Sesame Miso Salad with Salmon

Macadamia Nut Company Recalls Product with Undeclared Almonds and Cashews; Highlights the Need for Verifying Co-Manufacturers Allergen Controls

Mauna Loa Macadamia Nut Company LLC of Kea’au, HI is voluntarily recalling Mauna Loa Dark Chocolate Covered Macadamias (0.6oz and 4oz bags), due to the possible presence of undeclared almonds and cashews.  The recall was initiated after Mauna Loa’s internal quality control process identified that the affected batch, manufactured by a third-party co-manufacturer, contained undeclared almonds and cashews. Immediate action was taken to contain the affected product, notify the third-party co-manufacturer, alert consumers and distributors, and report the issue to the FDA.  The recalled Mauna Loa Dark Chocolate Covered Macadamias are packaged in 0.6oz and 4oz bags and were distributed to multiple retail locations in AZ, CA, CO, FL, HI, IL, ME, MI, NJ, OR, PA, TX, UT, VA, WA, WI, and Guam.

It is important for companies that use co-packers to understand the potential allergen risk at these co-manufacturers and that these co-manufacturers have a solid allergen control program in place, including appropriate allergen preventive controls.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mauna-loa-macadamia-nut-company-llc-issues-allergy-alert-undeclared-almonds-and-cashews-mauna-loa
Mauna Loa Macadamia Nut Company, LLC Issues Allergy Alert on Undeclared Almonds and Cashews in Mauna Loa Dark Chocolate Covered Macadamias (0.6OZ and 4OZ)
Summary
Company Announcement Date:  April 26, 2025
FDA Publish Date:  April 26, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared cashew, almond
Company Name:  Mauna Loa Macadamia Nut Company LLC
Brand Name:  Mauna Loa
Product Description:  Dark Chocolate Covered Macadamias