FDA Issues Warning Letters to a Host of Food Importers for Not Having FSVP in Place for Imported Foods

Over the past few weeks, FDA issued warning letters to a good number of importers for not having FSVP programs. 

Transworld International Trading Corp of .New York, NY did not develop, maintain, and follow an FSVP for some of the imported foods including each the following food products: chocolate imported from (b)(4) located in (b)(4) and chocolate imported from (b)(4), located in (b)(4).  Where a program was in place, the company did not meet requirements for verification as part of the company's FSVP plan for puffed snacks botanas (tortilla chips) in that the program was not functional.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/transworld-international-trading-corp-629674-07052022

Bolive, Inc. of Upland, CA did not develop an FSVP for the foods imported from the foreign suppliers indicated in the attached list and for: Halva and Tahini imported from foreign supplier (b)(4) in (b)(4) and Black Olives imported from foreign supplier (b)(4) in (b)(4)
Bolive, Inc. - 634004 - 07/05/2022 | FDA

Everyday Import & Export, Inc. dba Everyday Group LLC, of  Brooklyn, NY  did not develop an FSVP for any of the imported food products , including each of the following foods: (b)(4) imported from (b)(4) located in (b)(4), (b)(4) imported from (b)(4) located in (b)(4). and (b)(4) Chocolate Strawberry Flavor imported from (b)(4) located in (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/everyday-import-export-inc-dba-everyday-group-llc-628633-05262022


Greenfield Produce Imports, of St., Los Angeles, CA did not develop, maintain, and follow an FSVP for any of their imported foods including: Perishable and frozen cassava imported from (b)(4);
Fresh young coconut without green husk imported from (b)(4); and Fresh turmeric imported from (b)(4).
"During our inspection you provided documents you obtained from your foreign suppliers, including audit reports (which are not in English), a HACCP certificate, and a food safety certificate. However, the documents that are relevant to an FSVP are incomplete, and you did not provide a record of your review of the relevant documents or explain how they would apply to your FSVP program. Thus, these documents do not constitute an FSVP as required"
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/greenfield-produce-imports-629152-05102022

Dara Food LLC of Fairfield, NJ did not develop, maintain, and follow an FSVP as required by Section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop, maintain, and follow an FSVP for any imported foods including: Confections (chocolate candy bar) imported from (b)(4)
Sheep’s milk cheese imported from (b)(4)  and Baklava imported from (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dara-food-llc-631229-05312022

Flores Produce, Inc. of Chula Vista, CA did not develop, maintain, and follow an FSVP for your papayas imported from (b)(4).
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/flores-produce-inc-632024-06242022

North30 LLC,of Bellevue, WAdid not develop an FSVP for any of the imported foods including each of the following food products: Passion Fruit Sauce, imported from (b)(4), located in (b)(4)
Taro, imported from (b)(4) located in (b)(4)  Mesona Extract, imported from (b)(4), located in (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/north30-llc-633737-06242022

Jap Inc. dba Intercontinental Foods of Bellingham, WA did not develop, maintain, and follow an FSVP for any of the foods that you import, including: Brooke Bond Taj Mahal 450G imported from (b)(4), located in (b)(4) Brooke Bond Red Label Tea 1800G imported from (b)(4), located in (b)(4)
Lipton Yellow Label Tea 450G imported form (b)(4), located in (b)(4) Chilli Powder imported from (b)(4), located in (b)(4) 
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jap-inc-dba-intercontinental-foods-630247-05242022

Regino Produce, LLC of, Houston, TXdid not develop an FSVP for 85 of the 88 foods the company  imported, including: Fried Read-to-Eat Corn Chips imported from (b)(4), located in (b)(4)
Fresh Raw Serrano Peppers imported from (b)(4), located in (b)(4) Fresh Raw Lettuce imported from (b)(4), located in (b)(4) 
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/regino-produce-llc-632384-06272022

USDA Plans to Declare Salmonella an Adulterant in Breaded Stuffed Raw Chicken Products - Big Deal or Not a Big Deal

USDA released a statement that they will declare Salmonella an adulterant in breaded raw chicken products.  The reason is that these types of products have been involved in many Salmonella outbreaks where people tend to undercook them.  This occurs because they are partially cooked, or par-cooked, in order to set the breaded coating on the outside, and this leads consumers to think that they are fully cooked.  

From the USDA, "Since 1998, breaded and stuffed raw chicken products have been associated with up to 14 outbreaks and approximately 200 illnesses. Products in this category are found in the freezer section and include some chicken cordon bleu or chicken Kiev products. These products appear cooked, but they are heat-treated only to set the batter or breading and the product contains raw poultry. Continual efforts to improve the product labeling have not been effective at reducing consumer illnesses."

There has been a pushback against the declaration of Salmonella in raw poultry products.  Salmonella has been part of a chicken's natural microflora for a few hundred thousand years, so to completely eliminate Salmonella is not easy, certainly without changing a fresh chicken into some overly processed 'fresh-like' chicken.  But with breaded chicken products, they have already started the process of cooking, so going a bit further in terms of cooking to eliminate Salmonella may not be a big deal (although quality can be an issue in that the consumer will now recook a fully cooked item versus a partially cooked one potentially resulting in a drier, chewier product).  But the big deal is that once we start down this road, there will be a greater push to declare Salmonella an adulterant in all raw poultry products.


USDA Announces Action to Declare Salmonella an Adulterant in Breaded Stuffed Raw Chicken Products | USDA
USDA Announces Action to Declare Salmonella an Adulterant in Breaded Stuffed Raw Chicken Products

WASHINGTON, August 1, 2022 – The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) is announcing that it will be declaring Salmonella an adulterant in breaded and stuffed raw chicken products.

A Mass Establishment Recalls RTE Meat and Poultry Wraps After USDA Testing Finds Listeria Positive Product Sample

Rachael’s Food Corporation, a Chicopee, Mass. establishment, is recalling approximately 2,246 pounds of ready-to-eat meat and poultry wrap products that may be adulterated with Listeria monocytogenes.  The problem was discovered by FSIS during follow-up procedures after a routine FSIS product sample confirmed positive for Listeria monocytogenes.  There have been no confirmed reports of adverse reactions due to consumption of these products. 

Product was recalled from what looks to be a 5 day production window.  Based on coding, 22200 would indicate product was produced on July 19, 2022 and has a sell by of 8/3/22..a 14 or 15 day shelf-life depending on how you count the days.

https://www.fsis.usda.gov/recalls-alerts/rachaels-food-corporation-recalls-ready-eat-meat-and-poultry-wrap-products-due

Rachael’s Food Corporation Recalls Ready-To-Eat Meat and Poultry Wrap Products Due to Possible Listeria Contamination
RACHAEL'S FOOD CORPORATION

FSIS Announcement

WASHINGTON, July 30, 2022 – Rachael’s Food Corporation, a Chicopee, Mass. establishment, is recalling approximately 2,246 pounds of ready-to-eat meat and poultry wrap products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Ark Establishment Recalls Beef and Broccoli Product Because Contains Orange Chicken Resulting in Undeclared Egg

Conagra Brands, Inc., a Russellville, Ark. establishment, is recalling approximately 119,581 pounds of frozen beef products due to misbranding and undeclared allergens, specifically egg.  The products are labeled as beef and broccoli but contain orange chicken. These items were produced on May 26 and May 27, 2022. The following products are subject to recall [view labels]:

https://www.fsis.usda.gov/recalls-alerts/conagra-brands-inc--recalls-frozen-beef-products-due-misbranding-and-undeclared
Conagra Brands, Inc., Recalls Frozen Beef Products Due to Misbranding and Undeclared Allergens
CONAGRA BRANDS, INC.

FSIS Announcement

WASHINGTON, July 30, 2022 – Conagra Brands, Inc., a Russellville, Ark. establishment, is recalling approximately 119,581 pounds of frozen beef 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 egg, a known allergen, which is not declared on the product label.

Florida Pizza Company Recalls Pizza with Meat Because They Failed to Have USDA Inspection

Danny’s Sub and Pizza, a Cape Coral, Fla. establishment doing business as Danny’s Cuban Pizza, is recalling approximately 19,275 pounds of frozen meat pizza products that were produced without the benefit of federal inspection.  The problem was discovered during routine FSIS surveillance activities when it was determined that the meat pizza products were produced in an establishment that was not inspected by USDA.
If you are going to use meat on your pizza, it now become a USDA inspected product.


https://www.fsis.usda.gov/recalls-alerts/dannys-sub-and-pizza-recalls-meat-pizza-products-produced-without-benefit-inspection
Danny’s Sub and Pizza Recalls Meat Pizza Products Produced Without Benefit of Inspection
FSIS Announcement

WASHINGTON, July 28, 2022 – Danny’s Sub and Pizza, a Cape Coral, Fla. establishment doing business as Danny’s Cuban Pizza, is recalling approximately 19,275 pounds of frozen meat pizza products that were produced without the benefit of federal inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

HEB Recalls Ice Cream for Allergens After Packaging Error

H-E-B is voluntarily issuing an all-store recall for half gallon H-E-B Creamy Creations Light Mint Chocolate Chip Ice Cream due to an undeclared allergen, wheat.  The issue was discovered when H-E-B Creamy Creations Light Cookies & Cream Ice Cream was identified in some cartons labeled as H-E-B Creamy Creations Light Mint Chocolate Chip Ice Cream. H-E-B Creamy Creations Light Cookies & Cream Ice Cream contains wheat as an ingredient.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/h-e-b-issues-recall-h-e-b-creamy-creations-light-mint-chocolate-chip-ice-cream-due-mislabeling
H-E-B Issues Recall for H-E-B Creamy Creations Light Mint Chocolate Chip Ice Cream Due to Mislabeling
Products contain wheat, a known allergen, which is not declared on the product label
Summary
Company Announcement Date:  August 01, 2022
FDA Publish Date:  August 01, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Wheat
Company Name:   H-E-B
Brand Name:  H-E-B
Product Description:   Creamy Creations Light Mint Chocolate Chip Ice Cream

CA Company Recalls Nutritional Beverages Due to Processing Issues Resulting in Potential Bacterial Contaminants

 Lyons Magnus LLC (“Lyons Magnus” or the “Company”) today announced that it is voluntarily recalling nutritional and beverage products due to the potential for microbial contamination, including from the organism Cronobacter sakazakii. The list of recalled products does not include products intended for infants (i.e. under the age of one).  Preliminary root cause analysis shows that the products did not meet commercial sterility specifications.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lyons-magnus-voluntarily-recalls-53-nutritional-and-beverage-products-due-potential-microbial
Lyons Magnus Voluntarily Recalls 53 Nutritional and Beverage Products Due To The Potential For Microbial Contamination
Summary
Company Announcement Date:  July 29, 2022
FDA Publish Date:  July 29, 2022
Product Type:  Food & Beverages  Meal Replacements  
Reason for Announcement:  Due to the potential for microbial contamination, including Cronobacter sakazakii
Company Name:  Lyons Magnus LLC
Brand Name:  Lyons, Pirq, Glucerna, various
Product Description:  Nutritional and beverage products

Recall of Chocolate Covered Blueberries After Customer Finds Chocolate Covered Almonds in Package

Wilbur’s of Maine Chocolate Confections of Freeport, Maine is recalling its 8 oz resealable package of milk chocolate covered blueberries because they may contain undeclared chocolate covered almonds. The recall was initiated after a customer discovered chocolate covered almonds in a package (of milk chocolate covered blueberries). The blueberry packaging does not reveal the presence of almonds. Subsequent investigation indicates that the problem was caused by a temporary breakdown in the company’s packaging process. The process has been corrected and the company has instituted additional safety checks and corrective actions. 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wilburs-maine-chocolate-confections-issues-allergy-alert-undeclared-almonds-chocolate-covered
Wilbur’s of Maine Chocolate Confections Issues Allergy Alert on Undeclared Almonds in Chocolate Covered Blueberries
Summary
Company Announcement Date:  July 28, 2022
FDA Publish Date:  July 28, 2022
Product Type:  Food & Beverages  Snack Food Item
Reason for Announcement:  Undeclared almonds
Company Name:  Wilbur’s of Maine Chocolate Confections
Brand Name:  Milk chocolate covered blueberries
Product Description: Milk chocolate covered blueberries

Soup Base Recalled After Label Design Issue Results in Undeclared Allergens

Wismettac Asian Foods, Inc., Santa Fe Springs, CA is recalling 17.6 oz packages of Marutomo Dashi Soup Base because they may contain undeclared wheat and soy.  The recall was initiated after it was discovered that the product containing wheat and soybean was distributed in packaging that did not reveal the presence of wheat and soybean. Subsequent investigation indicates the problem was caused by a human error during product label checking process.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wismettac-asian-foods-issues-allergy-alert-undeclared-wheat-and-soy-dashi-soup-base
Wismettac Asian Foods Issues Allergy Alert on Undeclared Wheat and Soy in Dashi Soup Base
Summary
Company Announcement Date:  July 26, 2022
FDA Publish Date:  July 26, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Wheat and Soy
Company Name:  Wismettac Asian Foods, Inc.
Brand Name:  Marutomo
Product Description:  Dashi Soup Base