FDA Updates on FSMA Inspections for FY22

FDA inspections are beginning to pick back up after a slow down during COVID pandemic.

Specialty Foods Association
https://www.specialtyfood.com/news/article/fda-reveals-fsma-experience-fspca-annual-conference/
10/26/2022

FDA Reveals FSMA Experience at Annual Conference

Author:  Ron Tanner

FDA Reveals FSMA Experience at Annual Conference

FDA has emerged from the pandemic with a renewed emphasis—and a new approach—to inspecting manufacturers for compliance with the Preventive Controls for Human Food regulations of the Food Safety Modernization Act and to inspecting importers to determine whether they are following the Foreign Supplier Verification Program.

“Our inspections are still ebbing and flowing but we are moving in the right direction,” said Glenn Bass, deputy director, human and animal food operations—west, Office of Regulatory Affairs, FDA, during last week's Food Safety Preventive Controls Alliance Annual Conference. “We continue to rethink our field activities based on what we learned during the pandemic.”

FDA Issue Warning Letter to Spice Repacker

FDA issued a Warning Letter to El Gordo Spices of Dallas TX,  where herbs, spice, and seafood are repacked and warehoused.  During our inspection, FDA investigators found serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation - failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products 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)]. Based on the inspectional findings, the shelf stable ready-to-eat (RTE) Whole Dried Shrimp and Ground Dried Shrimp were found to be adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.

Further, FDA reviewed labels of repacked products (Ground Dried Shrimp, Whole Dried Shrimp, Sesame Seeds, Textured Soybeans, Ground Cumin, and Whole Bay Leaves) and found serious violations of the Food Labeling regulation.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/el-gordo-spices-llc-639957-09302022
WARNING LETTER

El Gordo Spices, LLC
MARCS-CMS 639957 — SEPTEMBER 30, 2022

CA Firm Recalls Cookies for Undeclared Almonds and Hazelnuts

Daiso California LLC of La Mirada, CA is recalling its Tiramisu Twist Cookies (sku 4562138450820) because the product contains almonds and hazelnuts, ingredients that are not identified on the packaging.   The recall was initiated after it was discovered that the Tiramisu Twist Cookie packaging did not adequately disclose the presence of the nuts. Sale of the product has been suspended, and Daiso California has pulled the product from store shelves.  There has been one reported case of allergic reaction to this product.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/daiso-issues-allergy-alert-tiramisu-twist-cookies-almonds-and-hazelnuts-not-identified-ingredients
Daiso Issues Allergy Alert on Tiramisu Twist Cookies Almonds and Hazelnuts Not Identified as Ingredients on Packaging
Summary
Company Announcement Date:  October 27, 2022
FDA Publish Date:  October 28, 2022
Product Type:  Food & Beverages  Bakery Product/Mix
Reason for Announcement:  Undeclared almonds and hazelnuts
Company Name:  Daiso California LLC
Brand Name:  Daiso
Product Description:  Tiramisu Twist Cookies

TX Establishment Recalls Shepard's Pie for Foreign Material - Copper wire

Lone Star Bakery, Inc., a China Grove, Texas establishment, is recalling approximately 5,740 pounds of beef shepherd’s pie products that may be contaminated with extraneous materials, specifically copper wire pieces.  The problem was discovered when the firm notified FSIS that they received consumer complaints reporting entwined copper wire embedded in beef shepherd’s pie products with a use by date of Sept. 23, 2023.  (Copper wire would indicate a maintenance related issue?)


https://www.fsis.usda.gov/recalls-alerts/lone-star-bakery-inc--recalls-beef-shepherds-pie-products-due-possible-foreign
Lone Star Bakery, Inc. Recalls Beef Shepherd’s Pie Products Due to Possible Foreign Matter Contamination
LONE STAR BAKERY, INC.

FSIS Announcement

WASHINGTON, Oct. 27, 2022 – Lone Star Bakery, Inc., a China Grove, Texas establishment, is recalling approximately 5,740 pounds of beef shepherd’s pie products that may be contaminated with extraneous materials, specifically copper wire pieces, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

MI Company Recalls Gelato for Undeclared Egg Allergen Due to Formulation Change

Zingerman’s Creamery of Ann Arbor, MI is recalling 173 pints of Paw Paw Gelato, 50 quarts of Paw Paw Gelato, 58 pints of Harvest Pumpkin Gelato, 10 quarts of Harvest Pumpkin Gelato that are currently out in commerce because it may contain undeclared Egg allergen.  The recall was initiated after it was discovered that Paw Paw and Harvest Pumpkin Gelato containing ‘Egg’ was distributed in packaging that ‘Egg’ was included on the “made in facility” allergens but not included on the ingredients and allergen declaration. Earlier this year, Zingerman's Creamery made some recipe changes to our gelato bases to include egg yolk, to improve the overall quality. All of our gelato labels were updated to reflect the egg yolk change as well. However, our seasonal flavors (Paw Paw and Harvest Pumpkin) were accidentally overlooked. Subsequent investigation indicates the problem was caused by human error of mislabeling.  (This is a label redesign oversight).


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/zingermans-creamery-issues-allergy-alert-undeclared-egg-paw-paw-and-harvest-pumpkin-gelato
Zingerman’s Creamery Issues Allergy Alert on Undeclared Egg in Paw Paw and Harvest Pumpkin Gelato
Summary
Company Announcement Date:  October 26, 2022
FDA Publish Date:  October 27, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared eggs
Company Name:  Zingerman’s Creamery
Brand Name:  Zingerman’s
Product Description:  Harvest Pumpkin gelato and Paw Paw gelato

FL Company Recalls Burger Patties After Distributor Repackages Them Without Inspection

New Universal Nourishment LLC, a Miami Beach, Fla. firm, is recalling approximately 368 pounds of beef burger patty products that were repackaged, relabeled and distributed without the benefit of federal [USDA] inspection.  The problem was discovered when FSIS received a complaint reporting product in commerce labeled with the mark of inspection for Est. 451B bearing labels that were not applied by the originating company. FSIS determined that the distributor repackaged and/or relabeled the beef patty products without the benefit of federal inspection and used the mark of inspection from an establishment without proper authorization.

https://www.fsis.usda.gov/recalls-alerts/new-universal-nourishment-llc-recalls-beef-burger-patty-products-produced-without
New Universal Nourishment LLC Recalls Beef Burger Patty Products Produced Without Benefit of Inspection
FSIS Announcement

WASHINGTON, Oct. 26, 2022 – New Universal Nourishment LLC, a Miami Beach, Fla. firm, is recalling approximately 368 pounds of beef burger patty products that were repackaged, relabeled and distributed without the benefit of federal inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

FL Company Recalls Biscotti for Undeclared Walnut Due to Mislabeling Issue

Sotto I Trulli INC/DBA Bombolo Biscotti, is recalling its Assorted Italian Cookies, because it contains Italian Wedding Cookies with undeclared walnut ingredient.  The recall was initiated after one of the store employees discovered that Italian Wedding Cookies were incorrectly labeled as Assorted Italian Cookies in packaging that did not reveal the presence of the walnut allergen. 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/sotto-i-trulli-inc-dba-bombolo-biscotti-issues-allergy-alert-undeclared-walnut-product
Sotto I Trulli, Inc. DBA Bombolo Biscotti Issues Allergy Alert on Undeclared Walnut in Product
Summary
Company Announcement Date:  October 24, 2022
FDA Publish Date:  October 25, 2022
Product Type:  Food & Beverages  Bakery Product/Mix  
Reason for Announcement:  Undeclared walnuts
Company Name:  Sotto i Trulli Inc. DBA Bombolo Biscotti
Brand Name:  Bombolo Biscotti
Product Description:  Assorted Italian Cookies

Sausage Products Recalled Due to Thin Blue Rubber Pieces

Bob Evans Farms Foods, Inc., a Xenia, Ohio establishment, is recalling approximately 7,560 pounds of Italian pork sausage products that may be contaminated with extraneous materials, specifically thin blue rubber.  The problem was discovered after the firm notified FSIS it had received consumer complaints reporting thin blue pieces of rubber in the product.  (A glove perhaps?)

https://www.fsis.usda.gov/recalls-alerts/bob-evans-farms-foods-inc--recalls-italian-pork-sausage-products-due-possible
Bob Evans Farms Foods, Inc., Recalls Italian Pork Sausage Products due to Possible Foreign Matter Contamination
FSIS Announcement

WASHINGTON, Oct. 21, 2022 – Bob Evans Farms Foods, Inc., a Xenia, Ohio establishment, is recalling approximately 7,560 pounds of Italian pork sausage products that may be contaminated with extraneous materials, specifically thin blue rubber, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

CO Company Recalls Sauce Made with Tamari Due to Undeclared Soy Allergen

Seed Ranch Flavor Co. of Boulder, CO, is voluntarily recalling its 5 fl ounce bottles of "Umami Everyday Sauce" and “Everything But The Sushi & Dumplings” sauce because they contain undeclared soy.  The recall was initiated after it was discovered that the soy-containing product was distributed in packaging that did not explicitly reveal the presence of soy. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production and packaging processes during a label redesign. Production of the products with incorrect labels have been suspended and allergen information clearly disclosed on corrected labels.

The product contains tamari...which is a fermented soybean product.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/seed-ranch-flavor-co-issues-allergy-alert-undeclared-soy-umami-everyday-sauce-and-everything-sushi
Seed Ranch Flavor Co Issues Allergy Alert on Undeclared Soy in "Umami Everyday Sauce" and “Everything But The Sushi & Dumplings” Sauce
Summary
Company Announcement Date:  October 23, 2022
FDA Publish Date:  October 24, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared soy
Company Name:  Seed Ranch Flavor Co.
Brand Name:  Seed Ranch Flavor Co.
Product Description:  Various sauces