FDA Warning Letters Issued to Food Importers Lacking FSVP for Foods Imported

For most recently released FDA Warning Letters (as of 10/10/23), five importers were cited for lacking FSVP programs for food products those companies import.

Kari-Fresh LLC  - Donna, TX
Did not develop an FSVP for any of the imported foods, including the following foods:
Fresh Cilantro imported from (b)(4), Fresh Persian Limes imported from (b)(4) and Fresh Green Onions imported from (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kari-fresh-llc-663158-09292023

Shantaba LLC - Austin, TX,
Did not develop an FSVP for any of the imported foods , including the following foods:
2-Minute Noodles imported from (b)(4)., Kesar Mango Pulp imported from (b)(4)., and Soya Wadi-Soya Chunks imported from (b)(4).
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shantaba-llc-664239-09082023

Tijuana’s Produce Inc., -  Vernon, CA 
Did not develop an FSVP for the foods from the foreign suppliers indicated in the attached list, including each of the following foods: Fresh Seedless Watermelon imported from (b)(4), located in (b)(4) and Fresh Cucumbers imported from (b)(4), located in (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tijuanas-produce-inc-661522-08242023

Ikal, Llc., of San Diego CA
Did not develop an FSVP for any of the imported foods, including each of the following:
Fresh avocados imported from (b)(4), Fresh avocados imported from (b)(4) and Fresh avocados imported from (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ikal-llc-660717-08072023

MKK Imports - Torrance, CA
Did not develop an FSVP for any foods that are imported, including:
Orange Fruit Jelly imported from (b)(4), Fried Potato Chips imported from (b)(4), and Baked Wheat Cracker imported from (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mkk-imports-660814-08282023

Updated Preventive Controls Training Highlights HACCP-link and Added Benefits Of Additional Controls

An article in the month's Food Safety Magazine titled FSPCA Preventive Controls Updated Curriculum Highlights—Advantages for Food Safety Management discusses the updated version of FSPCA's training curriculum. Version 2.0 marks a few noticeable changes in addition to updating content to address FDA guidance releases. One of those changes is a rearrangement of material to have additional emphasis placed on Process Preventive Controls or CCPs. This aligns better with traditional HACCP training. Another change was the use of additional examples to demonstrate when aspects of programs for Allergens, Supplier Control, and Sanitation become Preventive Controls.

The article also discusses the advantage of the Preventive Controls approach over HACCP. Using a more intensive control approach to aspects of sanitation, allergen control, and supplier control can go a long way in reducing some of the primary causes of recalls currently being issued by companies. This is certainly the case for allergens, where allergen related recalls due to lack of adequate control are too common of an occurrence.

The updated curriculum is expected in early 2024. If you have taken training using version 1.2 and still have questions regarding the development or implementation of you plan, you may want to consider attending this updated training. To make this more feasible, Penn State will offer the updated course to those who had previously taken the course through Penn State at a discounted price. More information to come on that.


FSPCA Preventive Controls Updated Curriculum Highlights—Advantages for Food Safety Management
The issuance of FDA guidance documents and feedback from FSPCA stakeholders prompted FSPCA to update and issue a new version of its training curriculum
https://www.food-safety.com/articles/8937-fspca-preventive-controls-updated-curriculum-highlightsadvantages-for-food-safety-management

OR Company Recalls Peanut Butter Bar for Undeclared Sesame

Betty Lou’s Inc., McMinnville, OR is voluntarily recalling 1.76oz (50g) packages of Stabilyze Dark Chocolate Peanut Butter, BB 05APR24 0053, due to undeclared sesame allergen.  The recall was initiated after it was discovered through an internal Betty Lou’s Inc labeling review and found that a natural peanut flavoring containing sesame oil, but sesame is not declared on label. This recall is being made with the knowledge of the U.S. Food and Drug Administration.





https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/betty-lous-inc-issues-allergy-alert-undeclared-sesame-stabilyze-dark-chocolate-peanut-butter
Betty Lou’s Inc. Issues Allergy Alert on Undeclared Sesame in Stabilyze Dark Chocolate Peanut Butter
Summary
Company Announcement Date:  October 11, 2023
FDA Publish Date:  October 12, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared sesame - Allergen
Company Name:  Betty Lou’s Inc.
Brand Name:  Stabilyze
Product Description:  Dark Chocolate Peanut Butter nutrition bar

Arkansas Ice Cream Company Recalls Product After Not Declaring Egg on the Label

Yarnell Operations LLC of Searcy, Arkansas, today said it is voluntarily recalling containers of Yarnell’s Guilt Free No Sugar Added Homemade Vanilla Ice Cream (48 ounces/1.5 quart) because the product may contain undeclared egg.  The recall was initiated after it was discovered during a label review that the product may contain undeclared egg.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/yarnell-operations-issues-allergy-alert-undeclared-egg-ice-cream
Yarnell Operations Issues Allergy Alert on Undeclared Egg in Ice Cream
Summary
Company Announcement Date:  October 11, 2023
FDA Publish Date:  October 12, 2023
Product Type:  Food & Beverages  Ice Cream/Frozen Dairy 
Reason for Announcement:  Undeclared Egg
Company Name:  Yarnell Operations LLC
Brand Name:  Yarnell’s Guilt Free
Product Description:  Guilt Free No Sugar Added Vanilla Ice Cream

FL Shop Recalls Packed Ice Cream Bars With No Allergen Labeling

PARADISE FLAVORS LLC of Marathon, Florida is recalling all Paradise Flavors ice cream bars because these products may contain undeclared allergens including peanuts, tree nuts (chestnuts, walnuts, hazelnuts, pecans, pine nuts, cashews), wheat, soy, milk, and color additives ( FD&C blue #1, blue #2, red #3, red #5, red #6, red #40, yellow #5 yellow #6, yellow #8).  The recall was initiated after the Florida Department of Agriculture and Consumers Services conducted an inspection of the facility and made the company aware that product labels failed to declare allergens including peanuts, tree nuts, wheat, soy, milk, and color additives.

The picture of the facility gives an idea of the small scope of the operation.  Too many of these small shops begin to distribute product without realizing there are applicable regulations such as allergen labeling. 

                                                 



https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/paradise-flavors-llc-issues-allergy-alert-undeclared-peanuts-tree-nuts-wheat-soy-milk-and-color
Paradise Flavors LLC Issues Allergy Alert on Undeclared Peanuts, Tree Nuts, Wheat, Soy, Milk, And Color Additives (Fd&C Blue #1, Blue #2, Red #3, Red#5, Red #6, Red #40, Yellow #5, Yellow #6 Yellow #8) All Paradise Flavors Ice Cream Bars
Summary
Company Announcement Date:  October 12, 2023
FDA Publish Date:  October 12, 2023
Product Type: Food & Beverages
Reason for Announcement:  Undeclared Peanuts, Tree Nuts, Wheat, Soy, Milk, and Color Additives -
Company Name:  Paradise Flavors LLC
Brand Name:  Paradise Flavors
Product Description:  Ice Cream Bars

FL Company Recalls Seltzer Product For Undeclared Coconut and Milk Allergens

Kula Brands LLC, of Miami FL, is recalling Kula Can - Pina Colada + Kratom Seltzer due to the presence of undeclared tree nuts (coconut) and milk.  The recall was initiated after it was discovered that product containing (the allergen) was distributed in packaging that did not reveal the presence of tree nuts (coconut) and milk. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production and packaging processes.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kula-brands-llc-issues-allergy-alert-undeclared-coconut-and-milk-kula-can-pina-colada-kratom-seltzer
Kula Brands LLC Issues Allergy Alert on Undeclared Coconut and Milk in Kula Can Pina Colada + Kratom Seltzer
Summary
Company Announcement Date:  October 06, 2023
FDA Publish Date:  October 06, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Tree Nut (Coconut) and Milk
Company Name:  Kula Brands LLC
Brand Name:  Kula Can
Product Description:  Pina Colada + Kratom Seltzer

CA Establishment Recalls Ham Product After Internal Testing Indicated Potential Listeria Contamination

USDA-FSIS is issuing a public health alert due to concerns that ready-to-eat (RTE) ham products produced by Sunnyvalley Smoked Meats, a Manteca, Calif. establishment, may be contaminated with Listeria monocytogenes. A recall was not requested because it is believed that the affected products are no longer in commerce.  The problem was discovered after the establishment’s laboratory testing indicated the product may be contaminated with Listeria monocytogenes. The establishment notified FSIS that some of the affected product was distributed into commerce.  There have been no confirmed reports of adverse reactions due to consumption of these products.

https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-kirkland-signature-ready-eat-ham-products-due
FSIS Issues Public Health Alert for Kirkland Signature Ready-To-Eat Ham Products Due to Possible Listeria Contamination
SUNNYVALLEY SMOKED MEATS

FSIS Announcement

WASHINGTON, Oct. 6, 2023 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert due to concerns that ready-to-eat (RTE) ham products produced by Sunnyvalley Smoked Meats, a Manteca, Calif. establishment, may be contaminated with Listeria monocytogenes. A recall was not requested because it is believed that the affected products are no longer in commerce.

MA Establishment Recalls Meatball Product For Undeclared Egg

USDA-FSIS is issuing a public health alert for a ready-to-eat (RTE) stuffed pepper soup with meatballs product due to misbranding and undeclared allergen - the product contains egg, a known allergen, which is not declared on the product label. The product was produced by Plenus Group of Lowell, MA.  The problem was discovered during a label review by the establishment.





https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-a-ready-eat-stuffed-pepper-soup-meatballs-product
FSIS Issues Public Health Alert for A Ready-To-Eat Stuffed Pepper Soup with Meatballs Product Due to Misbranding and Undeclared Allergen
PLENUS GROUP INC.

FSIS Announcement

WASHINGTON, Oct. 6, 2023 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert for a ready-to-eat (RTE) stuffed pepper soup with meatballs product due to misbranding and undeclared allergen - the product contains egg, a known allergen, which is not declared on the product label. FSIS is issuing this public health alert to ensure that consumers are aware that this product should not be consumed. A recall was not requested because the product is no longer available for purchase.

TX Firm Recalls Edible Cookie Dough Product After Packaging Issue Results in Undeclared Peanut

Cookies-N-Milk, of McKinney, TX is recalling their 6oz cups of "Chocolate Chip Edible Cookie Dough" because it may contain undeclared peanuts.  After receiving a notification from a distributor, the investigation indicates the problem occurred at the packaging stage.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cookies-n-milk-issues-allergy-alert-undeclared-peanuts-chocolate-chip-edible-cookie-dough
Cookies-N-Milk Issues Allergy Alert on Undeclared Peanuts in Chocolate Chip Edible Cookie Dough
Summary
Company Announcement Date:  October 04, 2023
FDA Publish Date:  October 04, 2023
Product Type:  Food & Beverages  Bakery Product/Mix  
Reason for Announcement:  Undeclared Peanuts
Company Name:  Cookies-N-Milk
Brand Name:  Cookies-N-Milk
Product Description:  Chocolate Chip Cookie Dough