FDA Issues Warning Letter to Importer After Remote Inspection Finds No FSVP

FDA issued a Warning Letter to EM Advisors LLC / Shop & Save Market of  Niles, IL after a remote FSVP inspection which found the firm had not developed or implemented a FSVP for imported
Bread Mix, Dough Bread Mix and Farmer’s Cheese..

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nem-advisors-llc-shop-save-market-613666-04152021
NEM Advisors LLC / Shop & Save Market
MARCS-CMS 613666 — APRIL 15, 2021

FDA Warning Letter to Another Firm Experiencing Two Allergen Related Recalls

FDA issued a Warning Letter to George DeLallo company after the company experienced two allergen related recalls in a short period of time.   Here are two different operations, but experiencing a similar issue of placing the wrong labels on the machine.

Recalled "Holiday Cookie Platter product after notification from a customer that it was mislabeled. [The] recalled Holiday Cookie Platter product contains pecans that were not declared on the label. In documentation provided to the Office of Human and Animal Food Operations Division 2 East Recall Coordinator on December 5, 2020, [the firm] indicated that a supervisor placed the wrong roll of labels on the labeling machine and that the incorrect bottom label with the ingredients statement was used."

On November 24, 2020, [the firm] recalled Provolini Antipasti product labeled as Garlic Mushrooms after notification by a customer that it was mislabeled. [the] recalled Provolini Antipasti contains milk, but the label for Garlic Mushrooms that was applied to the bag does not declare milk. In documentation provided to the Division Recall Coordinator on December 1, 2020, [the firm]indicated that a line worker placed the wrong label on one side of the labeling machine.

Here is another example of FDA taking enhanced action against a firm experiencing two allergen-related recalls.

George DeLallo Company, Inc.
MARCS-CMS 612553 — MARCH 30, 2021

FDA Issues Warning Letter to Firm After Two Allergen Related Recalls

FDA issued a Warning Letter to Hanover Foods after the company had two allergen related recalls where each occurred in different operations.

One recall occurred when Baked Rice Pudding was labeled with the ingredient list for Red Chicken Chili with Beans.  The problem was a "duplicate database in your labeling software that was subsequently deleted".

The second recall which occurred at another subsidiary was for Cheddar Flavored Popcorn incorrectly labeled as Butter Flavored Popcorn.  The Cheddar Flavored Popcorn contains milk but the ingredient list for Butter Flavored Popcorn did not declare this allergen. The firm "indicated that the error occurred when bags containing Cheddar Flavored Popcorn were inadvertently labeled as Butter Flavored Popcorn."

The important takeaway from this is that FDA is taking a stand for allergen labeling and is elevating its response when the same firm has multiple issues, even if those issues are in different operations/divisions.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hanover-foods-corporation-612551-03262021
Hanover Foods Corporation
MARCS-CMS 612551 — MARCH 26, 2021

Foodservice Provider Recalls Pork Product for Undeclared Soy

Hempstead Foodservice, a Hempstead, N.Y. establishment, is recalling approximately 972 pounds of pork chop products due to misbranding and undeclared allergens in that it contains hydrolyzed soy protein, which is not on the box label.  The problem was discovered through routine FSIS verification activities.

The product is a foodservice item where the pork items are in unlabeled clear plastic bags and those bags are then packed into a cardboard box.  The box is labeled as to which food item it contains, but there is no allergen listing.  The hydrolyzed soy product was likely injected to meat.

https://www.fsis.usda.gov/recalls-alerts/hempstead-foodservice-recalls-pork-products-due-misbranding-and-undeclared-allergens
Hempstead Foodservice Recalls Pork Products Due to Misbranding and Undeclared Allergens

WASHINGTON, May 1, 2021 – Hempstead Foodservice, a Hempstead, N.Y. establishment, is recalling approximately 972 pounds of pork chop 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 hydrolyzed soy protein, a known allergen, which is not declared on the product label.

CDC MMWR - 2019 Multistate Outbreak of Escherichia coli O26 Infections Linked to Raw Flour

CDC released a report in MMWR on the 2019 E. coil O26 outbreak linked to raw flour.

"Twenty-one cases were reported from nine states. The median age of patients was 24 years (range = 7–86 years); 71% were female. Three patients were hospitalized, and none died. Among 13 patients asked about flour exposures, six reported eating, licking, or tasting raw homemade dough or batter during the week before illness onset. Three patients reported eating raw dough or batter made with the same grocery store brand of all-purpose flour, including a patient who reported eating raw dough at a bakery in Rhode Island. Overall, of 18 patients with store information, 11 reported shopping at this same grocery store chain."

"Flour is increasingly recognized as a cause of STEC outbreaks (1–5). Raw flour is not a ready-to-eat product, and this outbreak highlights the continuing risk for illness associated with consumption of flour and raw dough or batter."

https://www.cdc.gov/mmwr/volumes/70/wr/mm7016a4.htm
Notes from the Field: Multistate Outbreak of Escherichia coli O26 Infections Linked to Raw Flour — United States, 2019
Weekly / April 23, 2021 / 70(16);600–601
Michael Vasser, MPH1,2; Jonathan Barkley, MPH3,4; Adam Miller, MS3,5; Ellen Gee6; Katherine Purcell7; Morgan N. Schroeder, MPH1; Colin Basler, DVM1; Karen P. Neil, MD1 (View author affiliations)

Ohio Establishment Recalls Meat Broth Products for Potential Hydraulic Oil After Discovery of Equipment Issue

More Than Gourmet, Inc., an Akron, Ohio establishment, is recalling approximately 6,896 pounds of ready-to-eat beef and veal broth and stock products that may be contaminated with extraneous materials, specifically hydraulic oil.  The problem was discovered by the establishment after identifying a malfunction in a piece of processing equipment.

https://www.fsis.usda.gov/recalls-alerts/more-gourmet-inc.-recalls-beef-and-veal-broth-and-stock-products-due-possible
More Than Gourmet, Inc. Recalls Beef And Veal Broth And Stock Products Due To Possible Foreign Matter Contamination

Ohio Food Company Recalls Caramel Rice Cakes for Undeclared Milk

Basic Grain Products, Inc. in Coldwater, Ohio, is voluntarily recalling 6.56-ounce bags of Kroger and Stop & Shop brand’s Caramel Rice Cakes because they may contain undeclared milk. The undeclared milk was discovered by internal control systems. This recall is being carried out with the knowledge of the U.S. Food and Drug Administration.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/basic-grain-products-inc-issues-allergen-alert-undeclared-milk-caramel-rice-cakes
Basic Grain Products, Inc. Issues Allergen Alert on Undeclared Milk in Caramel Rice Cakes
Summary
Company Announcement Date:  April 28, 2021
FDA Publish Date:  April 28, 2021
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared milk
Company Name:  Basic Grains Products, Inc.
Brand Name:  Kroger and Stop & Shop
Product Description:  Caramel Rice Cakes

Ohio Ice Cream Company Recalls Ice Cream After Internal Tests Find Presence of Listeria

Velvet Ice Cream of Utica, Ohio has announced it is voluntarily recalling all of its ice cream and sherbet products made on or after March 24, 2021 as a precaution because they have the potential to be contaminated with Listeria monocytogenes,  No illness or injury has been associated with the recalled products, which are being recalled in cooperation with the U.S. Food and Drug Administration. The issue was identified as a result of the company’s routine testing.  The products were distributed to Indiana, Kentucky, Ohio, and West Virginia through various drug stores, convenience stores and supermarkets

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/velvet-ice-cream-recalls-various-products-due-possible-listeria-risk
Velvet Ice Cream Recalls Various Products Due to Possible Listeria Risk
Summary
Company Announcement Date:  April 26, 2021
FDA Publish Date:  April 27, 2021
Product Type:  Food & Beverages
Reason for Announcement:  Potential Listeria monocytogenes contamination.
Company Name:  Velvet Ice Cream
Brand Name:  Multiple brand names
Product Description:  Ice Cream

Ohio Nut Company Recalls Crunchy Roasted Cheddar and Jalapeno Flavored Nuts for Undeclared Milk

Wolfies Roasted Nut Co. in Findlay, Ohio is voluntarily recalling its Crunchy Cheddar & Jalapeno Nuts due to an undeclared milk allergen. This recall has been initiated due to the ingredient label not stating a milk allergen. The issue was discovered during a routine inspection conducted by the Food & Drug Administration (FDA)

On the Wolfies company website, it looks as though milk is listed in the ingredient statement

Crunchy Roasted Cheddar & Jalapeno

NUTRITIONAL FACTS
Ingredients: Peanuts, water, flour, sugar, soy sauce, cayenne pepper, jalapeno pepper, salt,
onion, garlic. Cheddar Cheese (milk, salt, cheese cultures, enzymes), whey, partially hydrogentated
soybean oil, maltodextrin, reduced lactose whey, disodium phosphate, Blue Cheese (milk, salt,
cheese cultures, enyzmes), nonfat dry milk, citric acid, artificial color (yellow #5, yellow #6). No preservatives

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wolfies-roasted-nut-co-issues-voluntary-recall-its-crunchy-cheddar-jalapeno-nuts
Wolfies Roasted Nut Co. Issues Voluntary Recall of its Crunchy Cheddar & Jalapeno Nuts
Summary
Company Announcement Date: April 23, 2021
FDA Publish Date: April 23, 2021
Product Type: Food & Beverages
Reason for Announcement: Undeclared milk allergen
Company Name: Wolfies Roasted Nut Co.
Brand Name: Wolfies Roasted Nut Co.
Product Description: Crunchy Cheddar & Jalapeno Nuts