Europe - Bottle of Champagne Contaminated With the Drug Ecstasy Kills One and Sickens 8

One man died and 8 others hospitalized in Germany and the The Netherlands after drinking champagne spike with a high level of the drug Ecstasy.  It is unknown how the bottles became laced with the drug.  The news report stated that the bottles of Moët & Chandon Ice Impérial were purchased on the internet.
"Toxicology reports found the champagne contained 1,000 times the normal dose of ecstasy, so much that the beverage had turned purple, according to the Daily Beast. Police do not believe the drinkers were aware of the drug or had added it themselves".

Clearly a case of intentional contamination.  Perhaps the bottles were spiked as a means to ship the drug and then were inadvertently sold?


https://www.insider.com/luxury-moet-champagne-spiked-with-ecstasy-kills-man-12-poisoned-2022-3
Man dies and 12 people are taken ill after drinking a $480 bottle of champagne spiked with ecstasy
Bethany Dawson Mar 6, 2022, 11:46 AM

A man has died and 12 became ill in Germany and The Netherlands after drinking a bottle of luxury champagne laced with ecstasy.

RTE Chicken Salad Recalled After Supplier of Salad Dressing Discovers Foreign Material Issue

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) chicken salad product containing a Food and Drug Administration (FDA) regulated salad dressing that has been recalled by the producer due to concerns that the salad dressing may contain hard plastic.  The problem was discovered when an FSIS inspected establishment received notification from their salad dressing supplier that the salad dressing, which is regulated by FDA, may contain hard plastic.

https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-chicken-salad-products-containing-fda-regulated
FSIS Issues Public Health Alert for Chicken Salad Products Containing FDA-Regulated Dressing that has been Recalled due to Foreign Material Contamination
R & G FINE FOODS, INC.

FSIS Announcement

WASHINGTON, March 10, 2022 – 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) chicken salad product containing a Food and Drug Administration (FDA) regulated salad dressing that has been recalled by the producer due to concerns that the salad dressing may contain hard plastic. FSIS is issuing this public health alert to ensure that consumers are aware that these products should not be consumed.

Dark Chocolate Espresso Beans Recalled for Containing Chocolate Covered Peanuts Instead

Albanese Confectionery Group, Inc. of Merrillville, Indiana is voluntarily recalling Albanese® Dark Chocolate Espresso Beans, 9 oz tub, because it may contain an undeclared peanut allergen. The recall was initiated after it was discovered that Dark Chocolate Panned Peanuts were inadvertently packaged in the Dark Chocolate Espresso Bean tubs.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/albanese-confectionery-group-inc-recalls-dark-chocolate-espresso-bean-9-oz-tub-because-undeclared
Albanese Confectionery Group, Inc. Recalls Dark Chocolate Espresso Bean 9 Oz. Tub Because of Undeclared Peanut Allergen
Summary
Company Announcement Date:  March 10, 2022
FDA Publish Date:  March 10, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared peanuts
Company Name:  Albanese Confectionary Group, Inc.
Brand Name:  Albanese
Product Description:  Dark Chocolate Espresso Beans

Spinach and Artichoke Dip Recalled After Incorrect Packaging Results in Undeclared Allergen

Fairmont Foods, Inc. of Fairmont, MN is recalling corrugated boxes of Schwan’s Brand “Spinach and Artichoke Dip” with date code P82013 xxxx due to undeclared soy and wheat.  The recall was initiated after it was discovered that the incorrect packaging had been used.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fairmont-foods-inc-issues-recall-spinach-and-artichoke-dip-product-due-misbranding-and-undeclared
Fairmont Foods, Inc. Issues Recall of Spinach and Artichoke Dip Product Due to Misbranding and Undeclared Soy and Wheat Allergens
Summary
Company Announcement Date:  March 10, 2022
FDA Publish Date:   March 10, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared soy and wheat
Company Name:  Fairmont Foods, Inc.
Brand Name:  Schwan’s
Product Description:  Spinach and Artichoke Dip

Frozen Bagels Recalled After Mispackaging Results in Undeclared Egg Allergen

Damascus Bakery OPCO LLC is voluntarily recalling one production lot (#12031) of Bantam Classic Bagels due to an incorrect item being placed in the carton with an undeclared egg allergen.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/damascus-bakery-recalls-one-lot-bantam-classic-bagels
Damascus Bakery Recalls One Lot of Bantam Classic Bagels
Summary
Company Announcement Date:  March 02, 2022
FDA Publish Date:  March 09, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared eggs
Company Name:  Damascus Bakery OPCO LLC
Brand Name:  Bantam Classic
Product Description:  Stuffed Bagels with Cream Cheese

OH Firm Recalls 'Einkorn' Products for Not Declaring Wheat Because Einkorn is Wheat

Stutzman Farms of Millersburg, Ohio is voluntarily recalling all products containing einkorn as the product labels do not declare wheat, a known allergen, on the product label. Stutzman Farms became aware of the misbranding issue after it was brought to our attention by the Ohio Department of Agriculture.

From the Einkorn.com website "Einkorn is the oldest wheat known to scientists, and is considered man’s first wheat. The term einkorn is derived from the German language and interpreted to mean “single grain”. Einkorn wheat is known in taxonomy as either Triticum boeoticum (wild wheat), or Triticum monococcum (domesticated species). Domesticated and wild forms of wheat may be considered either as separate species, or as Triticum monococcum’s subspecies."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/stutzman-farms-issues-voluntary-recall-its-einkorn-products-undeclared-wheat-allergen
Stutzman Farms Issues a Voluntary Recall of its Einkorn Products for an Undeclared Wheat Allergen
Summary
Company Announcement Date:  March 08, 2022
FDA Publish Date:  March 09, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared wheat
Company Name:  Stutzman Farms
Brand Name:  Stutzman Farms
Product Description:  Products containing einkorn: berries, flour, pretzel, more.

Abbott Expanded Recall of One Lot of Baby Formula

Abbott is voluntarily recalling one lot of Similac PM 60/40 (Lot # 27032K80 (can) / Lot # 27032K800 (case)) manufactured in Sturgis, Michigan. This is in addition to lots of Similac®, Alimentum® and EleCare® powder formula that were voluntarily recalled on Feb. 17. The action comes after learning of the death of an infant who tested positive for Cronobacter sakazakii and who we were informed had consumed Similac PM 60/40 from this lot.  Importantly, no distributed product has tested positive for the presence of Cronobacter sakazakii. Additionally, recently tested retained product samples of Similac PM 60/40 Lot # 27032K80 (can) / Lot #27032K800 (case) were negative for Cronobacter.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abbott-voluntarily-expands-recall-powder-formulas-manufactured-one-plant
Abbott Voluntarily Expands Recall of Powder Formulas Manufactured at One Plant
Summary
Company Announcement Date:  February 28, 2022
FDA Publish Date:  March 07, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Consumer complaints regarding Cronobacter sakazakii, Salmonella Newport
Company Name: Abbott
Brand Name:  Similac, Alimentum, and EleCare
Product Description:  Powder Infant Formula

CA Establishment Recalls Jerky Products After USDA Sampling Finds Listeria Positive Sample

Boyd Specialties, LLC, a Colton, Calif. establishment, is recalling approximately 1,634 pounds of ready-to-eat (RTE) jerky 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.

The product was packed under a variety of label brands and was shipped to retail locations in Alabama, California, Connecticut, Michigan, New Jersey, North Carolina, Pennsylvania, and Texas

Currently, the recall is limited to one day of production (Feb 23, 2022), but with recalls of this nature, it would not be surprising to see this recall expanded.

https://www.fsis.usda.gov/recalls-alerts/boyd-specialties-llc-recalls-jerky-products-due-possible-listeria-contamination
Boyd Specialties, LLC Recalls Jerky Products Due to Possible Listeria Contamination
BOYD SPECIALTIES LLC

FSIS Announcement

WASHINGTON, March 4, 2022 – Boyd Specialties, LLC, a Colton, Calif. establishment, is recalling approximately 1,634 pounds of ready-to-eat (RTE) jerky products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

FDA Releases Final Guidance for Conducting A Voluntary Recall

FDA released its finalized guidance for conducting a voluntary recall.  The document, "Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C", was issued as a draft in 2019.   It discusses the various elements of a recall including having a recall plan, conducting training, maintaining records, and interacting with the FDA.  There were some minor changes from the draft including adding terminology, including the term "market withdrawals".

It would be worthwhile downloading this document and reviewing it against your current recall plan.

FDA Guidance
Guidance--Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C (fda.gov)
Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C Guidance for Industry and FDA Staff

INTRODUCTION

The purpose of this guidance is to clarify FDA’s recommendations for industry and Agency staff 
regarding timely initiation of voluntary recalls under 21 CFR part 7, subpart C – Recalls (Including Product Corrections) – Guidance on Policy, Procedures, and Industry Responsibilities. The guidance discusses what preparations firms in a distribution chain, including manufacturers and distributors, should consider making to establish recall initiation procedures; to ensure timely identification of, and response to, product problems that might lead  to a recall; and to promptly issue recall communications and press releases or other public notices. It also discusses preparations firms in the distribution chain should consider making to ensure timely responses to a recall communication. Additionally, it discusses how FDA assists firms with carrying out their recall responsibilities to protect the public health from distributed products in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other laws administered by FDA.

This guidance applies to voluntary recalls of products subject to FDA’s jurisdiction, including any food, drug, and device intended for human or animal use, any cosmetic and biological product intended for human use, any tobacco product intended for human use, and any item subject to a quarantine regulation under 21 CFR part 1240. This guidance applies to devices that are electronic products regulated as radiology devices subject to 21 CFR part 892. It does not apply to electronic products subject to 21 CFR parts 1003 and 1004. 

MO Company Recalls Beef Sticks After Recognition The Gluten Free Declaration Wrong Because Product Contains Wheat

Frickenschmidt Foods LLC, a Lockwood, Mo. establishment, is recalling approximately 5,795 pounds of ready-to-eat beef stick products due to misbranding, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains and declares wheat as an ingredient but has an incorrect statement of “gluten free” on the label. The problem was discovered when the distribution company notified the establishment that the product is labeled as “gluten free” but lists wheat in the ingredients statement.

https://www.fsis.usda.gov/recalls-alerts/frickenschmidt-foods-llc-recalls-ready-eat-beef-stick-products-due-misbranding
Frickenschmidt Foods LLC Recalls Ready-to-Eat Beef Stick Products Due to Misbranding
FRICKENSCHMIDT FOODS LLC
FSIS Announcement

WASHINGTON, Feb. 22, 2022 – Frickenschmidt Foods LLC, a Lockwood, Mo. establishment, is recalling approximately 5,795 pounds of ready-to-eat beef stick products due to misbranding, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains and declares wheat as an ingredient but has an incorrect statement of “gluten free” on the label.

Chocolate Covered Cherries Recalled After Product Inadvertently Mixed with Almond Containing Product

Torn & Glasser of Pomona, CA is recalling 231 cases (2,772 units) of Dark Chocolate Covered Cherries due to an undeclared allergen. The Dark Chocolate Covered Cherries may also contain Dark Chocolate Almonds which are Tree Nuts (Almond) allergen.  The recall was initiated after it was discovered that product containing Dark Chocolate Covered Cherries was mixed with Dark Chocolate Covered Almonds in the bag. Subsequent investigation indicates that some Dark Chocolate Covered Almonds were used for Dark Chocolate Covered Cherries by Production personnel.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/urgent-torn-glasser-recalls-sprouts-farmer-market-dark-chocolate-covered-cherries-12-oz-because
Urgent: Torn & Glasser Recalls Sprouts Farmer Market Dark Chocolate Covered Cherries 12 Oz. Because of Undeclared Almond Allergen
Summary
Company Announcement Date:  March 04, 2022
FDA Publish Date:   March 04, 2022
Product Type:  Food & Beverages  Snack Food Item  
Reason for Announcement:  Undeclared almonds
Company Name:  Torn & Glasser
Brand Name:  Sprouts Farmers Market
Product Description:  Dark Chocolate Covered Cherries

Bakery Items Recalled After Label Printer Misses The Allergen Statement

The Third Synthesis Inc DBA Chicago Sweet Connection Bakery is issuing a voluntary recall for fresh baked Coffee Cakes (Various Flavors) and fresh baked Paczkis (Various Flavors) produced between February 21st, 2022 to February 23rd, 2022 because the label does not declare Egg, Milk, and Wheat.
The recall was initiated after it was discovered that the allergen statement was not correctly printing on labels due to a computer error. The label was being cut off before the allergen statement could print. Products produced after these dates have been corrected.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/third-synthesis-inc-issues-allergy-aert-undeclared-egg-milk-and-wheat-allergen-statement
The Third Synthesis Inc Issues Allergy Alert on Undeclared Egg, Milk, and Wheat Allergen Statement
Summary
Company Announcement Date:  February 28, 2022
FDA Publish Date:  March 03, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared egg, wheat, milk allergen
Company Name:  Chicago Sweet Connection Baker
Brand Name:  Chicago Sweet Connection Bakery
Product Description:   Coffee cake and paczkis varieties

USDA Issues Warning for Product that Contains Unlabeled Allergen Due to Supplier Error

USDA - FSIS is issuing a public health alert for various ready-to-eat (RTE) meat products containing a FDA regulated seasoning mix that has been recalled by the producer, PS Seasoning of Iron Ridge, Wis., due to concerns that the seasoning mix may contain undeclared wheat.   The problem was discovered when the FSIS inspected establishments received notification from their seasoning supplier that the seasoning mix, which is regulated by FDA, may contain undeclared wheat. The establishments then notified FSIS of the issue. FSIS and FDA are coordinating on this issue.

This is a supplier issue with mislabeling that affects downstream producers.  This supplier should have had an Allergen Preventive Control in place to ensure proper labeling.  But as the purchaser of that product, a company should understand the need for that supplier to have such controls in place.  How would they know that there is such a need?  If a spice supplier is packing various products with different allergen groupings, they would need such controls.

https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-ready-eat-meat-products-containing-fda-regulated
FSIS Issues Public Health Alert for Ready-to-Eat Meat Products Containing FDA-Regulated Seasoning Mix That Has Been Recalled Due to Misbranding and an Undeclared Allergen

FDA Issues Warning Letter After Recall Due to Undeclared Allergen Due to Mislabeling Error

FDA issued a Warning Letter to Cedar’s Mediterranean Foods Inc. after a October 2021 recall where the company's Organic Mediterranean Hommus was labeled with the ingredient declaration for its Organic Everything Hommus in that the finished product label did not declare a major food allergen--tree nuts (i.e., Pine Nut).

The company provided FDA the reason for mistake - "stated that the root cause of the problem was that an employee failed to follow the label change over procedure and performed an unauthorized label change. The email also stated that you retrained all employees that perform labeling, took disciplinary action against the employee that performed the unauthorized change, and that you will develop a label reconciliation program."   In response FDA stated "it appears that you did not implement adequate allergen preventive controls."

The responsibility should not be on one employee, but a Preventive Control that incorporates monitoring and verification by additional employees.

FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cedars-mediterranean-foods-inc-623473-02112022
Cedar’s Mediterranean Foods Inc.
MARCS-CMS 623473 — FEBRUARY 11, 2022

First Possible Case of COVID-19 Transmission from Deer to Human

Researchers may have identified one of the first cases of transmission of COVID-19 from white tailed deer to a person.  We have known that white tailed deer can carry the COVID-19 virus.   (Plus they are notorious non-maskers.)   A specific strain of COVID that was common among the deer crowd popped up in a human.  And that human was said to be associating with the white tail deer.  (We do not now the extent of this association, but one could guess that the human probably entered into this 'association' unmasked.

Researchers to not want to get anyone alarmed.  No reason for having to wear a mask while hiking in the woods or forcing the deer into wearing a mask through passing mandated mask-for-deer legislation.

Live Science
https://www.livescience.com/deer-to-human-covid-19-transmission
1st possible case of deer-to-human COVID-19 transmission reported
By Rachael Rettner 3/1/22
So far, it seems to be an isolated COVID-19 case.

More Dried Plums Recalled

Alli & Rose LLC is recalling dried plums due to the potential presence of lead.  The product was sold at Costco Wholesale in four states: Alaska, California, Oregon and Washington.

Dried Plums Recall Information
Summary
Company Announcement Date:  February 15, 2022
FDA Publish Date:  February 24, 2022
Product Type:  Food & Beverages
Reason for Announcement:  potential to be contaminated with lead
Company Name:  Alli and Rose LLC
Brand Name:  Snak Yard
Product Description:  Dried Plums/ saladitos

Imported Apple Pulp Recalled After Linked to Salmonella Cases

Vadilal Industries (USA) Inc. of Newark, NJ is voluntarily recalling two batches of frozen Custard Apple Pulp because it has the potential to be contaminated with Salmonella.  The recall was initiated after FDA received a single complaint reporting 5 illnesses and FDA sampling revealed the presence of Salmonella in the product.  The product is imported from India.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vadilal-industries-usa-recalls-custard-apple-pulp-because-possible-health-risk
Vadilal Industries (USA) Recalls "Custard Apple Pulp" Because of Possible Health Risk
Summary
Company Announcement Date:  February 22, 2022
FDA Publish Date:  February 22, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Salmonella
Company Name:  Vadilal Industries Inc.
Brand Name:  Vadilal
Product Description:  frozen custard apple pulp

NJ Importer Issued Warning Letter for Not Having FSVP

FDA issued a Warning Letter to Patidar Trade, Inc. of North Brunswick, NJ because they were in violoation fo teh Foreign Supplier Verification Program Regulation (FSVP) which requires companies to conduct a hazard analysis and enact verification procedures for items that are imported.  The comany 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, the company did not develop, maintain, and follow an FSVP for any of the imported foods including each of the following food products:

Wheat flour imported from (b)(4)

Rice flour imported from (b)(4)

Phool makhana imported from (b)(4)

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/patidar-trade-inc-619282-01062022
Patidar Trade, Inc.
MARCS-CMS 619282 — JANUARY 06, 2022

Inaccurate Web Posting on Recalls - Creating Confusion and Increasing Apathy

This past week, a number of outlets posted news stories stating that Giant Eagle was recalling frozen green peppers due to Listeria. The problem is, the recall occurred months ago.  These news geniuses posted it as it was current.   And then criticized the company for not having the recall on their website, and the FDA as well.

The first sighting was the lawyer-sponsored websites:

• https://www.foodsafetynews.com/2022/02/giant-eagle-recalls-frozen-bags-of-diced-green-peppers-after-testing-finds-listeria/
• https://foodpoisoningbulletin.com/2022/giant-eagle-diced-green-peppers-recalled-for-possible-listeria/

And other web-based news outlets such as MSN

• https://www.msn.com/en-us/foodanddrink/foodnews/urgent-frozen-food-recall-check-your-freezer-for-these-contaminated-veggies/ar-AAU5Ywe?ocid=uxbndlbing

All one would have to have done was to read the notice, or call the company.

Enforcement Report (fda.gov)

Event Details

Event ID:  89147

Voluntary / Mandated:  Voluntary: Firm initiated

Product Type:  Food

Initial Firm Notification of Consignee or Public:  

All products were distributed to only Giant Supermarket's in the following States: MD, PA, WV, OH and IN

Recalling Firm: 

Giant Eagle, Inc.

101 Kappa Dr

Pittsburgh, PA 15238-2809

United States

Recall Initiation Date:  11/29/2021

So now the store has to handle calls from confused consumers.  Over the long haul, people will play less attention if the information being provided is shoddy. 

The problem is that too many do not go back to the original source.  Because a lawyer-sponsored website posts something, that does not make it fact.  Rarely if ever, do they post their references.  In the end, reporters need to research this better before posting.

FDA Investigators Issue Warning for Product Out of Family Dollar's Rat-Infested Distribution Center

The FDA issued a warning for products sold at over 400 Family Dollar Stores after an FDA investigation found that the retail chain's distribution warehouse was heavily infected with rats...thousands of rats.

"The U.S. Food and Drug Administration is alerting the public that several categories of FDA-regulated products purchased from Jan. 1, 2021, through the present from Family Dollar stores in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee may be unsafe for consumers to use. The impacted products originated from the company’s distribution facility in West Memphis, Arkansas, where an FDA inspection found insanitary conditions, including a rodent infestation, that could cause many of the products to become contaminated."

"Following a consumer complaint, the FDA began an investigation of the Family Dollar distribution facility in West Memphis, Arkansas, in January 2022. Family Dollar ceased distribution of products within days of the FDA inspection team’s arrival on-site and the inspection concluded on Feb. 11. Conditions observed during the inspection included live rodents, dead rodents in various states of decay, rodent feces and urine, evidence of gnawing, nesting and rodent odors throughout the facility, dead birds and bird droppings, and products stored in conditions that did not protect against contamination. More than 1,100 dead rodents were recovered from the facility following a fumigation at the facility in January 2022. Additionally, a review of the company’s internal records also indicated the collection of more than 2,300 rodents between Mar. 29 and Sep. 17, 2021, demonstrating a history of infestation."

"Family Dollar, Inc. is initiating a voluntary retail level product recall of certain products regulated by the U.S. Food and Drug Administration (FDA) that were stored and shipped to 404 stores from Family Dollar Distribution Center 202 in West Memphis, Arkansas from January 1, 2021 through the present due to the presence of rodents and rodent activity at Family Dollar Distribution Center 202."

https://www.fda.gov/news-events/press-announcements/fda-alerts-public-potentially-contaminated-products-family-dollar-stores-six-states

FDA Alerts the Public to Potentially Contaminated Products from Family Dollar Stores in Six States

 For Immediate Release:

February 18, 2022

FDA Issues Health Alert Regarding Infant Formula Linked to Cronobacter and Salmonella Illnesses, Michigan Facility Issues Recall

FDA issued a health warning for infant formula made at Abbott's Michigan facility after that product was linked to complaints of four infant illnesses from three states. "The FDA, along with CDC and state and local partners are investigating four consumer complaints of infant illness related to products from Abbott Nutrition’s Sturgis, MI facility received from 9/20/2021 to 1/11/2022. All of the cases are reported to have consumed powdered infant formula (IF) produced from Abbott Nutrition’s Sturgis, MI facility. These complaints include three reports of Cronobacter sakazakii infections and one report of Salmonella Newport infection in infants. All four cases related to these complaints were hospitalized and Cronobacter may have contributed to a death in one case."

From the CDC..."Cronobacter multi-species complex (formerly Enterobacter sakazakii) is a group of gram-negative bacteria that exists in the environment and which can survive in very dry conditions. The natural habitat for Cronobacter is not known. It has been found in a variety of dry foods, including powdered infant formula, skimmed milk powder, herbal teas, and starches. It has also been found in wastewater. Cronobacter illnesses are rare [2 to 4 cases per year], but they are frequently lethal for infants and can be serious among people with immunocompromising conditions and the elderly."

Cronobacter can cause diarrhea and urinary tract infections in people of all ages, but infection can be very serious in infants (<12 months), especially during the first few weeks after birth. Although cases are rare, the organism can cause a dangerous blood infection (sepsis) or make the linings surrounding the brain and spinal cord swell (meningitis).

"Cronobacter infections have been associated with consumption of reconstituted powdered infant formula. In several outbreak investigations, Cronobacter has been found in powdered infant formula that had been contaminated in the factory. In other cases, Cronobacter might have contaminated the powdered infant formula after it was opened at home or elsewhere. Powdered infant formula is not sterile. Manufacturers report that, using current methods, it is not possible to produce sterile powdered infant formula. At the factory, Cronobacter could get into formula powder if contaminated raw materials are used to make the formula, or if the formula powder touches a contaminated surface in the manufacturing environment."

https://www.fda.gov/food/outbreaks-foodborne-illness/fda-investigation-cronobacter-and-salmonella-complaints-powdered-infant-formula-february-2022
FDA Investigation of Cronobacter and Salmonella Complaints: Powdered Infant Formula (February 2022)
Do not use recalled Similac, Alimentum, or EleCare powdered infant formula
02/18/2022

Arizona Company Recalls Yogurt Raisons After Packaging Equipment Potentially Contaminated with Peanut Allergen

Lehi Valley Trading Company of Mesa, Arizona is issuing a nationwide recall of 8,10 and 12.3 oz packages of Yogurt Raisins, because it may contain undeclared Peanut Allergen.  The recall was initiated after it was discovered that equipment used to package this product may have come in contact with product containing Peanut Allergens.

One may guess that this is a situation where the packaging had run peanut-containing product and then without proper cleaning, packaged the non-peanut yogurt raison product.   Clearly an Allegan Preventive Control was not properly implemented at this step. 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lehi-valley-trading-company-issues-allergy-alert-undeclared-peanut-allergen-yogurt-raisins
Lehi Valley Trading Company Issues Allergy Alert on Undeclared Peanut Allergen in Yogurt Raisins
Summary
Company Announcement Date:  February 17, 2022
FDA Publish Date:  February 17, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared peanuts
Company Name:  Lehi Valley Trading Company
Brand Name:  Snack Worthy, Woody’s Smokehouse, Texas Best Smokehouse
Product Description:  Yogurt Raisins

Canned Chili Recalled When Customer Discovers Product in Can is Cream of Chicken Soup

Morgan Foods, an Austin, Ind., establishment, is recalling approximately 2,205 pounds of Skyline chili due to misbranding and undeclared allergens, the product contains milk, wheat, and soy (allergens) and are not declared on the product label.  The problem was discovered by consumers who reported to the company that the cans labeled as chili contained cream of chicken soup.

https://www.fsis.usda.gov/recalls-alerts/morgan-foods-recalls-skyline-chili-products-due-misbranding-and-undeclared-allergens
Morgan Foods Recalls Skyline Chili Products due to Misbranding and Undeclared Allergens

FDA Warning Letter Issued to Kansas Bakery for Significant GMP Issues

FDA issued a Warning Letter to a Kansas Bakery after an extended inspection in August of 2021.  The company had not issued a response to the observations that were noted on the  Inspection Form 483.

There are a number of issues cited under each of these items.
Item 1 - Lots of bugs including cockroaches and flies.
Item 2 - Really dirty equipment

Item 3 - Poor employee practices when working with RTE foods

Looking at the facility on Google Street View, it is hard to believe that FDA was able to find this shack-like building.

FDA Warning Letter

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bakery-project-inc-dba-delano-bakery-617718-01042022
Bakery Project Inc. dba Delano Bakery
MARCS-CMS 617718 — JANUARY 04, 2022

CT Ice Cream Company Expands Listeria Related Recall To Include all Products

The Royal Ice Cream Company, Inc. of Manchester, CT is expanding its recall of February 6 to include all products manufactured at the facility within the expiration date (as we guessed).   According to the release, "The recall was initiated by Royal Ice Cream after FDA sampling revealed the presence of Listeria monocytogenes on processing equipment. The company is holding future product and testing before releasing distribution of the products as FDA and the company continue their investigation as to what caused the problem."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/royal-ice-cream-company-inc-expands-recall-all-products-within-expiry-because-possible-health-risk
The Royal Ice Cream Company, Inc. Expands Recall All Products Within Expiry Because of Possible Health Risk
Summary
Company Announcement Date:  February 11, 2022
FDA Publish Date:  February 12, 2022
Product Type:  Food & Beverages
Ice Cream/Frozen Dairy  Foodborne Illness
Reason for Announcement:  Listeria monocytogenes
Company Name:  The Royal Ice Cream Company, Inc.
Brand Name:  Royal Ice Cream, Batch, Ronny Brook, and Others
Product Description:  Ice Cream Products

More Enoki Mushrooms Recalled After Sampling Finds Listeria Risk

Two companies are conducting recalls of enoki mushroom due to the potential for Listeria contamination.  

• CONCORD FARMS of Vernon, CA is recalling its 5.25oz (150g) enoki mushrooms, Lot #045633 grown in Korea, after sampling by California Dept of Health (CDPH)
• Jan Fruits Inc. of VERNON, CA is recalling all its cases of its 200g/7.05oz packages of ENOKI MUSHROOM (Product of Taiwan) because it has the potential to be contaminated with Listeria monocytogenes.  The potential for contamination was discovered after a retail sample collected and analyzed by California Department of Public Health (CDPH) and revealed the presence of Listeria monocytogenes in 7.05 oz. package of Enoki mushroom.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/concord-farms-recalls-enoki-mushrooms-due-possible-health-risk-0
Concord Farms Recalls Enoki Mushrooms Due to Possible Health Risk
Summary
Company Announcement Date:  February 09, 2022
FDA Publish Date:  February 10, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Listeria monocytogenes
Company Name:  Concord Farms
Brand Name: Concord Farms
Product Description:  Enoki Mushrooms 

Additional Companies Recall Dried Plums for Lead Levels in Violation of California's Prop 65

Additional companies issued recalls of dried plums for potential to be contaminated from lead.  In the notices, we can see that companies are issuing recalls after testing by the CA State Laboratory found samples were in violation concerning the Prop 65.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/american-gourmet-recalls-saladitos-dry-salted-plums-because-possible-health-risk
American Gourmet Recalls Saladitos Dry Salted Plums Because of Possible Health Risk
Summary
Company Announcement Date:  February 10, 2022
FDA Publish Date:  February 10, 2022
Product Type:  Food & Beverages  Snack Food Item
Reason for Announcement:  Potential to be contaminated with lead
Company Name:  American Gourmet
Brand Name:  American Gourmet
Product Description:  Saladito (Dried Salted Plums)

Europe - Ongoing Salmonella Outbreak Associated with Eggs Affects Close to 300

The European Center of Disease Prevention and Control (ECDC) provided a report of an ongoing Salmonella outbreak of 272 cases and 2 deaths (Denmark (n=3), France (n=216), the Netherlands (n=12), Norway (n=7), Spain (n=22), and the UK (n=12)). The organism was linked to an earlier outbreak in 2019 which point to a Spanish farm, although the data suggests a wider distribution where "there may be multiple heterogeneous sources of S. Enteritidis ST11, and the outbreak strain could also be circulating at other farms, inside or outside Spain."

European Centre for Disease Prevention and Control
https://www.ecdc.europa.eu/en/publications-data/multi-country-outbreak-salmonella-enteritidis-sequence-type-st11-infections
Multi-country outbreak of Salmonella Enteritidis sequence type (ST)11 infections linked to eggs and egg products

Three Food Importers Issued Warning Letters for Not Having Required FSVP for Imported Food Products

FDA issued Warning Letters to three food importers for not having FSVP for the items they import.

• Molino Enterprises One, Inc., located at 392 E 197th Street, Bronx, NY did not develop, maintain, and follow an FSVP for imported whole wheat breadsticks.
• Ding Tea Balboa located at 5945 Balboa Ave., San Diego, CA 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, did not develop an FSVP for any of the foods imported.
• VHRK Food Inc., located at 810 Bonnie Lane, Elk Grove Village, IL.did not develop an FSVP for any of the foods imported, including the following  Dry dates powder, Brown Chori (peas), Black pepper, and Sun dried gooseberries

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/molino-enterprises-one-inc-619323-01072022
Molino Enterprises One, Inc.
MARCS-CMS 619323 — JANUARY 07, 2022

Chicago Kimchi Operation Receives a Deserved Warning Letter

FDA issued a Warning Letter to 5,000 Years Foods of Chicago IL, a company that produces kimchi.  Basically,  the company downloaded some record keeping logs from the internet to make it look like they had controls in place, but between the lack of real controls and a slew of GMP issues that made this far to much to provide in a short summary.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/5000-years-foods-inc-617797-01272022
5,000 Years Foods, Inc.

FDA Issues Warning Letter to Dairy Powder Packer with Serious Salmonella Contamination Issues in Facility

FDA issued a Warning Letter to OFP ingredients after an inspection of their tolling operation for dry milk powder processing located in Oconomowoc, Wisconsin.  The facility processes agglomerated milk powders that are sold for further blending into beverages or for further packaging, and are considered RTE because they are consumed without further processing to significantly minimize biological hazards.  
 

The biggest concern was that FDA found Salmonella on environmental samples which demonstrated a lack of control.  "FDA laboratory analysis confirmed 10 of 174 environmental swabs collected were positive for Salmonella Cubana. Of these positive findings, three positive swabs were collected from the (b)(4) room, a room that you consider a primary pathogen control area where products are exposed to the environment and include the following locations: a crack in the wall and floor junction adjacent to (b)(4); the floor and stair junction of the mezzanine level which employees climb to access ribbon blenders; and the floor drain cover adjacent to the mezzanine stairs. Additionally, three positive swabs were collected from the agglomeration room, including the equipment framework under Line (b)(4)."

Further, this Salmonella strain was determined to be a resident organism.  Again, FDA - "Whole genome sequencing (WGS) was conducted on the Salmonella isolates obtained from the 2021 FDA environmental samples, and the current WGS analysis determined that the 2021 isolates matched isolates from three other environmental samples including FDA sample 437365, FDA sample 892439, and FDA sample 940886, which were collected from this facility location in 2009, 2016, and 2017, respectively. The presence of the same strain of Salmonella over multiple years indicates there has been a resident pathogen in your facility since at least 2009."

The facility was trying to control the environment through prerequisite programs rather than establishing this as a Sanitation Preventive Control.  The company's own environmental testing program had found salmonella, but they never did sufficient corrective action to eliminate the organism.  In addition, GMP issues seemed to be spreading the organism (fork lifts with positive samples on the wheels).

History has shown that facilities with this level of contamination will be hard pressed to rid itself of this resident Salmonella.


https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ofp-ingredients-llc-617124-12072021

OFP Ingredients LLC

MARCS-CMS 617124 — DECEMBER 07, 2021

Iowa Creamery Issued Warning Letter for Not Knowing How to Label Food Products Properly

FDA issued a Warning Letter to Picket Fence Creamer of Woodward, Iowa after finding twelve flavors of ice cream and three flavors of cheese curds contained undeclared ingredients and sub-ingredients.  From the notice, the company failed to identify ingredients and also failed to detail the makeup of certain ingredients (listing the sub-ingredients).  Makes you wonder if they were controlling allergens from product to product.

While a small farm producer, they were distributing their food items to retail stores.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/picket-fence-creamery-llc-618726-01142022
Picket Fence Creamery LLC

MARCS-CMS 618726 — JANUARY 14, 2022

FDA Issues Warning Letter to LA Seafood Company for Not Having HACCP Plan

FDA issued a Warning Letter to D&C Seafood of Venice, LA for not have a HACCP plan in place for thier seafood products - 1) king mackerel and wahoo to control the food safety hazards of histamine formation, 2) king mackerel and barracuda to control the hazard of ciguatera toxin, and 3) king mackerel, wahoo, barracuda, and cobia to control the hazard of undeclared allergens.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dc-seafood-inc-617675-09152021
WARNING LETTER
D&C Seafood, Inc

MARCS-CMS 617675 — SEPTEMBER 15, 2021

Imported Enoki Mushrooms Recalled After State Laboratory Finds Listeria

Golden Medal Mushroom Inc. of Los Angeles, CA is recalling all cases of its 200g/7.05-ounce packages of Enoki Mushrooms, lot # 300511, product of China, because it has the potential to be contaminated with Listeria monocytogenes.  The potential for contamination was discovered after routine testing by Michigan Department of Agriculture and Rural Development revealed the presence of Listeria monocytogenes in 200gram package of Enoki mushroom.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/golden-medal-mushroom-inc-recalls-enoki-mushrooms-because-possible-health-risk-0
Golden Medal Mushroom Inc. Recalls Enoki Mushrooms Because of Possible Health Risk
Summary
Company Announcement Date:  February 03, 2022
FDA Publish Date:  February 04, 2022
Product Type:  Food & Beverages
Reason for Announcement: Listeria Monocytogenes
Company Name:  Golden Medal Mushroom Inc.
Brand Name:  Golden Medal Mushroom Inc.
Product Description:  Enoki Mushrooms

CT Firm Recalls Ice Cream After FDA Sampling Finds Listeria on Equipment

The Royal Ice Cream Company, Inc. of Manchester, CT is recalling specific lots of Batch Ice Cream Brand Vanilla, Ginger, and Mocha Chip Ice Cream, because it has the potential to be contaminated with Listeria monocytogenes.  The recall was initiated by Royal Ice Cream after FDA sampling revealed the presence of Listeria monocytogenes on processing equipment. The company is holding future product and testing before releasing distribution of the products as FDA and the company continue their investigation as to what caused the problem."

At this point, one day code comprising 3 products are being recalled.  Would not be surprised to see this recall expand, especially since the problem has not yet been identified.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/royal-ice-cream-company-inc-recalls-batch-ice-cream-brand-vanilla-ginger-and-mocha-chip-ice-cream
The Royal Ice Cream Company, Inc. Recalls Batch Ice Cream Brand Vanilla, Ginger, and Mocha Chip Ice Cream Because of Possible Health Risk
Summary
Company Announcement Date:  February 04, 2022
FDA Publish Date: February 04, 2022
Product Type: Food & Beverages
Reason for Announcement: Listeria Monocytogenes
Company Name:  The Royal Ice Cream Company, Inc.
Brand Name:  Batch Ice cream
Product Description:  Vanilla, Ginger, and Mocha Chip Ice Cream

Three Companies Recall Salted Plum Products Due to Lead Contamination

EL CHAVITO, INC. of San Diego, CA is recalling all lots of Saladitos Dried Salted Plums and Saladitos Enchilados Salted Plums With Chili because while La Fiesta Food Products, La Mirada California is recalling all lots of Saladitos Con Chile(Salted Plums with Chili) and A&E Corrales LLC, Seattle, WA is recalling Saladitos Dried Salted Plums With Chili because these products have the potential to be contaminated with lead.

No reason on how the lead was detected or where it originated.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/el-chavito-inc-recalls-saladitos-dried-salted-plums-and-saladitos-enchilados-salted-plums-chili
El Chavito, Inc. Recalls Saladitos Dried Salted Plums and Saladitos Enchilados Salted Plums with Chili Because of Possible Health Risk

Summary

Company Announcement Date:  February 03, 2022

FDA Publish Date:  February 03, 2022

Product Type:  Food & Beverages

Reason for Announcement:  potential to be contaminated with lead

Company Name:  EL CHAVITO, INC.

Brand Name:  El Chavito®

Product Description:  Saladitos Dried Salted Plums and Saladitos Enchilados Salted Plums With Chili

Salad Dressings Recalled for Undeclared Egg

Conagra Brands, Inc. (NYSE: CAG), is voluntarily recalling a limited amount of Wish-Bone Thousand Island and Chunky Blue Cheese dressings due to egg in the product, which is not declared on the product label.  While there was no reason stated for how the error was identified or how it occurred, both products do contain egg yolk so it is likely that the wrong back label was applied.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/conagra-brands-issues-voluntary-allergy-alert-undeclared-egg-wish-boner-thousand-island-and-chunky
Conagra Brands Issues Voluntary Allergy Alert on Undeclared Egg in Wish-Bone® Thousand Island and Chunky Blue Cheese Dressings
Summary
Company Announcement Date:  January 28, 2022
FDA Publish Date:  January 31, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared egg
Company Name:  Conagra Brands, Inc.
Brand Name:  Wish-Bone
Product Description:  Salad dressings

Consumer Reports - Test Results for Frozen Produce

Consumer Reports released their testing results of frozen produce.  Nothing special to report regarding pathogens or nutrient quality.  Their testing did not yield any pathogenic bacteria.  Which we would generally expect.   From a nutrient perspective, they found that frozen is generally comparable to fresh.

That being said, it is always important to follow proper handling and preparation procedures.  From time to time, we can encounter contamination issues, such as with Listeria.  While the study did not look for viruses or parasites, and although a low risk, these too have been found.  https://www.cdc.gov/parasites/cyclosporiasis/outbreaks/foodborneoutbreaks.html

https://www.consumerreports.org/food-safety/are-frozen-fruits-and-vegetables-healthy-and-safe-a1002196402/
Are Frozen Fruits and Vegetables Healthy and Safe?
CR tested more than 300 samples of frozen produce for bacteria that commonly cause foodborne illness

"For our tests, we looked for E. coli, listeria, and salmonella, types of bacteria that commonly cause foodborne illness, in eight frozen categories—avocado, berries, corn, mangoes, peaches, pineapple, spinach, and smoothie mixes. In total, we included 369 items from big brands, private label, and store brands, including 365 by Whole Foods, Blendtopia, Birds Eye, Campoverde, Dole, Great Value, O Organics, and Trader Joe’s."

FSIS Issues Public Health Alert for Listeria-contaminated RTE Chicken Salad Produced by GA Establishment

USDA-FSIS issued a public health alert for ready-to-eat (RTE) chicken salad products produced by Simply Fresh Market, a Marietta, Ga after company tested product and found a sample positive for Listeria monocytogenes.   The RTE chicken salad with apples and walnuts items were produced on Jan. 17, 2022 and have an expiration date of January 25 [a date which has already passed].


https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-ready-eat-chicken-salad-products-due-possible

FSIS Issues Public Health Alert for Ready-To-Eat Chicken Salad Products Due to Possible Listeria Contamination

WASHINGTON, Jan. 28, 2022 – 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) chicken salad products produced by Simply Fresh Market, a Marietta, Ga. establishment, may be contaminated with Listeria monocytogenes. A recall was not requested because the known affected product is no longer available in commerce for consumers to purchase.

FDA Warning Letter - Fresh Cut Produce Facility

FDA issued a Warning Letter to Onofrio's Fresh Cut of New Haven CT, a produce processing facility for RTE fresh-cut produce (e.g., onions, peppers, celery, broccoli, cantaloupe, watermelon, and kiwi).  The FDA collected environmental samples from various areas in the processing facility and found Listeria monocytogens in several areas.

FDA stated issues with the Preventive Control Plan as well as with GMPs.  With regard to the Food Safety Plant, while the hazard analysis considered pathogen contamination at the cutting and assembling processing steps. it determined that a preventive control was not necessary due to CGMPs/SSOPs and a prior wash step. However, "RTE fresh-cut produce is exposed to the environment during cutting and assembly and does not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. Thus, environmental pathogens are a hazard likely to occur in the absence of preventive controls (i.e., sanitation controls)."

FDA’s current inspection included the collection of environmental swabs on July 13, 2021, during the production of RTE fruits and vegetables; four (4) of seventy-one (71) swabs were confirmed positive for L. monocytogenes. The positive findings include a mixing room floor drain adjacent to a table where RTE celery was being cut, forklift wheels, a wheel on a rolling cart holding shrimp and seafood salad ingredients, and a packing room broom handle

One item stated in the Warning Letter was a bit surprising in that FDA seems to be suggesting a Supplier Preventive Control for the produce.  The report stated that the company "did not establish supply-chain controls for pathogens such as L. monocytogenes, pathogenic E. coli, and Salmonella at the receiving step for incoming produce. [The] hazard analysis indicated that pathogens will be controlled at a later wash step. However, [the] produce wash does not effectively destroy pathogens on the whole produce, as indicated by an email on July 20, 2021, from a representative of [the] supplier of (b)(4) sanitizer, which is used in your produce wash."  This may be difficult if the company is bringing in raw, unwashed produce.

The facility had a number of GMP issues which would exasperate the situation.  Condensation, poor plumbing, inadequate cleaning of equipment (both contact and non-contact surfaces),  and poor food handling practices.


https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/onofrios-fresh-cut-inc-618502-01102022
WARNING LETTER
Onofrio's Fresh Cut, Inc.
MARCS-CMS 618502 — JANUARY 10, 2022

Birthday Cakes Recalled for Allergens After Packaged Wrong

Siren of San Francisco, CA is issuing a voluntary recall of Siren Birthday Cake 1.7oz Bites because they may contain undeclared cashews and almond butter.  Due to a consumer notification about an allergic reaction, the recall was initiated after it was discovered that product containing cashew and almond butter was distributed in packaging that did not reveal the presence of cashew and almond butter on the ingredient deck.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/siren-issues-voluntary-allergy-alert-undeclared-cashews-and-almond-butter-birthday-cake-bites
Siren Issues a Voluntary Allergy Alert on Undeclared Cashews and Almond Butter in Birthday Cake Bites
Summary
Company Announcement Date:  January 27, 2022
FDA Publish Date:  January 27, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Cashews and Almond Butter
Company Name:  Siren Snacks
Brand Name:  Siren
Product Description:  Birthday Cake Bites

Two Importers Receive Warning Letters for Lack of FSVP

FDA issued Warning Letters to two import companies for not having FSVP programs in place for the products they import.

Green Food Ingredients, LLC of Burr Ridge IL did not establish written procedures for ensuring that appropriate supplier verification activities are conducted in accordance with 21 CFR 1.506(b), and you did not document your determination of the appropriate supplier verification activity or activities in accordance with 21 CFR 1.506(d).

HK Produce Group Inc. DBA Y2S Trading Inc. of  Long Island City, NY 11101 received an inspection was initiated, in part, based on FDA samples finding Listeria monocytogenes (L. monocytogenes), a human pathogen, in four (4) entries of fresh enoki mushrooms.  Inspectors found the company 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 an FSVP for any of the foods imported.

"This inspection was initiated, in part, based on FDA samples finding Listeria monocytogenes (L. monocytogenes), a human pathogen, in four (4) entries of fresh enoki mushrooms, three (3) of which were from (b)(4) located in (b)(4) and one (1) from (b)(4) located in (b)(4). The samples were collected from entries B7S-2105311-2, 677-0332940-8, 677-0332919-2 and B7S-2106092-7, all imported by your firm. We placed fresh enoki mushrooms from (b)(4) under Import Alert (IA) #99-23 “Detention Without Physical Examination of Produce Due to Contamination With Human Pathogens,” on July 20, 2021 and IA #99-35 “Detention Without Physical Examination of Produce That Appears To Have Been Prepared, Packed, Or Held Under Insanitary Conditions,” on November 1, 2021. "

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/green-food-ingredients-llc-616669-10212021
WARNING LETTER
Green Food Ingredients, LLC

Gogi Berry Snacks Recalled After State Lab Finds Undeclared Sulfites

BCS International Corp. Long Island City, NY, is recalling its 4.5 ounce, 6 ounce and 9 ounce containers and 5 pound packages of “Dr. Snack Goji Berry” food treats because they contained undeclared sulfites.  The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of sulfites in “Dr Snack Goji Berry” which were not declared on the label. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reactions in some asthmatics.  Analysis of the “Dr. Snack Goji Berry” revealed they contained 13.6 milligrams per serving.

CFR Title 21 Chapter I Subchapter B Part 130 Subpart A § 130.9 
(a) Any standardized food that contains a sulfiting agent or combination of sulfiting agents that is functional and provided for in the applicable standard or that is present in the finished food at a detectable level is misbranded unless the presence of the sulfiting agent or agents is declared on the label of the food. A detectable amount of sulfiting agent is 10 parts per million or more of the sulfite in the finished food.

FARP 
"Sulfites are also prohibited from certain uses in the U.S. Sulfites may not be used in products such as meats that serve as a good source of vitamin B1 because sulfites can scavenge that vitamin from foods. In 1986, following the identification of numerous cases of sulfite-induced asthma occurring on ingestion of green or fruit salads treated with sulfites, FDA prohibited the use of sulfites on fruits and vegetables intended to be served raw or presented fresh to the public (Fed. Regist. 51:25021-25026, 1986). The only exception is sulfite use on minimally processed potatoes sliced or shredded for frying where sulfite use is still permitted (although FDA has a long-standing, though never finalized, proposal to ban that use also). Sulfite use as a fungicide during the shipment of fresh table grapes is regulated by the U.S. Environmental Protection Agency, but the concentration of SO2 residues on the table grapes as consumed must be <10 ppm total SO2."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bcs-international-corp-issues-alert-undeclared-sulfites-dr-snack-goji-berry
BCS International Corp. Issues Alert on Undeclared Sulfites in “Dr. Snack Goji Berry”
Summary
Company Announcement Date:  January 19, 2022
FDA Publish Date:  January 21, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared sulfites
Company Name:  BCS International Corp.
Brand Name:  Dr. Snack
Product Description:  Goji berry

Frozen Chopped Spinach Recalled After Testing Finds Listeria

Frozen Food Development is voluntarily recalling specific lots of Lidl branded 12-ounce packages of Frozen Chopped Spinach because the product has the potential to be contaminated with Listeria monocytogenes.  The potential for contamination was noted after routine testing revealed the presence of Listeria monocytogenes in 12-ounce packages of Lidl Frozen Chopped Spinach.  The production of the product has been suspended while FDA and Frozen Food Development continue to investigate the source of the problem.  The recalled Frozen Chopped Spinach was distributed in Lidl retail stores in GA, SC, NC, VA, MD, DE, NY, NJ, and PA.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/frozen-food-development-recalls-lidl-branded-chopped-spinach-because-possible-health-risk
Frozen Food Development Recalls Lidl Branded Chopped Spinach Because of Possible Health Risk
Summary
Company Announcement Date:  January 19, 2022
FDA Publish Date:  January 19, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Listeria Monocytogenes
Company Name:  Frozen Food Development
Brand Name:  Lidl
Product Description:  Frozen Chopped Spinach

Organic Mac n' Cheeze (Fake Cheese) Recalled After Third Party Testing Finds Milk Allergen

Amy’s Kitchen of Petaluma, California is initiating a voluntary Class I recall of Lot 60J0421 of the Vegan Organic Rice Mac & Cheeze due to the potential of having trace amounts of milk, which is not declared on the product label.  The recall was issued "After receiving a test result from a third-party laboratory indicating one of the meals in the lot contained trace amounts of milk protein,"

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amys-kitchen-voluntarily-issues-allergy-alert-undeclared-milk-single-lot-vegan-organic-rice-mac
Amy’s Kitchen Voluntarily Issues Allergy Alert on Undeclared Milk in a Single Lot of Vegan Organic Rice Mac & Cheeze
Summary
Company Announcement Date:  January 19, 2022
FDA Publish Date:  January 19, 2022
Product Type:  Food & Beverages  Organic Food / Home Grown   
Reason for Announcement:  Undeclared Milk
Company Name:  Amy’s Kitchen
Brand Name:  Amy’s
Product Description:  Amy’s Vegan Organic Rice Mac & Cheese

FDA Issue Report on Salmonella Outbreak Linked to Leafy Greens from Indoor Growing Facility

FDA released their report on a 2021 Salmonella outbreak that was linked to packaged leafy greens produced at a Controlled Environmental Agriculture (CEA) indoor hydroponic operation [a fancy indoor greenhouse].  The outbreak occurred in July and August of 2021 and was caused by Salmonella Typhimurium which infected 31 people and resulted in 4 hospitalizations.

One would think that product produced in a controlled setting would be free from pathogens.  However, there were many opportunities for contamination and a lack of control.  And an indoor greenhouse is not much different than a processing facility where controls are needed.  While a definitive source was not found, here is a brief summary of some of the issues"

• The operation stored its nutrient-rich growth media used in an outdoor location that was not adequately protected from potential sources of contamination such as animal intrusion, bird droppings, or water runoff.
• The use of production pond water, while not intended to be an issue with leafy greens final product, but control of the water was questioned and there were inadequate controls for the water itself, with FDA isolating a different strain of Salmonella (not the one involved in the outbreak.
• Harvesting equipment lacked adequate control, and condensate with the facility.
• Inadequate validation support for cooling greens after packaging.
• Issues with storm water retention pond in close proximity to the facility (25ft).  This pond did test positive for the outbreak strain.
• The firm did not adequately document that cleaning and sanitizing of equipment, tools, and buildings used in growing operations is routinely conducted in accordance with the firm’s procedures

FDA highlighted the recommendations that focused on the need to better understand the microbial risks and put in place better controls.
The full report can be found here - https://www.fda.gov/media/155402/download

Investigation Report: Factors Potentially Contributing to the  Contamination of Packaged Leafy

Greens Implicated in the Outbreak of Salmonella Typhimurium During the Summer of 2021

https://www.fda.gov/media/155402/download