FDA Warning Letter to CA Bakery for Having No Food Safety Plan and Having GMP Issues

FDA issued a Warning Letter to The Bonami Baking Company, Inc. of  Pittsburg, CA, a manufacturer of ready-to-eat (RTE) bakery products.  Basically, the company did not have a Food Safety Plan, so there was no evaluaiton for allergens or pathogens or mycotoxins.   On top of that, there was numerous GMP issues with a high number of insect-related sightings.  Finally, there were some misbranding issues.

Now, if one looks at the compay website, it looks like a legitimate operation. 

Bonami Bakery – Bay Area Bakery Shop (thebonamibakery.com)

FDA Warning Letter

The Bonami Baking Company, Inc.
MARCS-CMS 633746 — SEPTEMBER 07, 2022

FDA Issues Warning Letter to MA Fudge Processing Company

FDA issued a Warning Letter to Winfrey's Olde English Fudge, Inc. of  Rowley, MA, a producer of ready-to-eat (RTE) enrobed chocolates and fudge, including Milk Chocolate Pretzels and Milk Chocolate Peanut Butter Mini Eggs.

1. You did not conduct a hazard analysis for each type of food manufactured, processed, packed, or held at your facility to identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control - 

• "Did not identify and evaluate the hazard of allergen cross-contact as a known or reasonably foreseeable hazard to determine whether it requires a preventive control. The company manufactures multiple products with different allergen profiles on the same day and on shared equipment, which can result in allergen cross-contact without appropriate controls"

FDA Issues Updated Version of Allergen Guidance for Comment

FDA issued updated Q&A guidance documents (5th edition) on allergen labeling.   The original document (4th edition) was spit into two sets....one being the updated set of Q&A which is labeled as 5th ed. Draft, and the other being those original Q&A are in the document labeled 5th ed. Final.  (Why you may ask?  So the updated or Draft set of Q&A can be made available or open to comment while the Final set of Q&A is not.)

So for our discussion, the Draft version is more important as that represents new or updated thinking by FDA.  (Draft - https://www.fda.gov/media/163454/download)

Here are the primary items discussed in the Draft Guidance:
Sesame is now included, although this fact is not up for comment.
Ingredients and bulk ingredients used in further manufacturing must have allergen declarations.

Incidental allergens must be declared (soy lecithin, for example, used as a processing aid)

Spice and seasoning mixes must declare allergens.

Dietary supplements using roots, leaves stems and bark from tree nuts do not.

Genetic engineering - if allergen is produced, it must be stated.

Specific tree nuts must be listed - the entire list is provided.

The allergen statement as placed on the package is discussed.

The use on multipacks of food within a master pack.

Food ingredients that are derived from allergenic foods (highly refined oils, etc)

Incidental additives is discussed.

Also a section on Dietary supplements.


https://www.fda.gov/media/163454/download
Constituent Updates

Center for Food Safety and Applied Nutrition

________________________________________

FDA Issues Guidances on Food Allergen Labeling Requirements

Today, the U.S. Food and Drug Administration (FDA) issued two guidance documents about food allergen labeling requirements to help the food industry meet the requirements to list any major food allergen on the labels of FDA-regulated foods. Food labels are a powerful tool to help protect consumers with food allergies. Consumers can avoid ingredients they may be allergic or sensitive to in a food by looking for specific allergen labeling and reading the ingredient list.

FDA Issues Warning Letter to VA Spout Operation

FDA issued a Warning Letter to Happy Sprout Inc. of Springfield, VA after determining that the mung bean and soybean sprout products were adulterated (prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health).

1. "Did not establish and implement a written environmental monitoring plan that is designed to identify Listeria species or Listeria monocytogenes.  "The cleaning and sanitizing methods that you use are not adequate to control Listeria species, as evidenced by FDA findings of Listeria species (not monocytogenes) in seven (7) environmental swabs collected during the inspection and a finished product sample collected from a retail location.""
2. "Did not establish and implement a written sampling plan to test spent sprout irrigation water (SSIW) or in-process sprouts for pathogens as specified in 21 CFR 112.147 and in accordance with 21 CFR 112.144(b). You stated that you do not sample SSIW or in-process sprouts and that you were unsure if your sprouting operation has ever tested SSIW or in-process sprouts for any pathogen, including Escherichia coli O157:H7 or Salmonella spp."
3. "Did not sanitize food contact surfaces you use to grow, harvest, pack, or hold sprouts before contact with sprouts or seeds or beans used to grow sprouts as required by 21 CFR 112.143(b). On May 23, 2022, investigators observed your sanitation practices after packaging ready-to-eat soybean sprouts. You did not apply sanitizer solution on any food contact surface. Instead, your employees rinsed equipment with water and (b)(4). Investigators observed your firm packing mung bean sprouts on May 24, 2022, without applying sanitizer prior to packing the sprouts. In addition, when an employee was asked about the frequency of sanitation activities, the employee stated that sanitizer is applied, “(b)(4).” Your General Manager also stated that while (b)(4) cleaning is conducted (b)(4), the (b)(4) is deep cleaned and sanitized"
4. "Did not train personnel who handle (contact) covered produce or food contact surfaces, as required by 21 CFR 112.21, and personnel who conduct covered activities or who supervise personnel who handle covered produce or food contact surfaces as required by 21 CFR 112.22. For example, farm management stated that employees were trained approximately ten (10) years ago. The timeframe of (b)(4) for employee training does not meet the requirement of at least once annually, as required by 21 CFR 112.21(a). In addition, training must be conducted in a manner that is easily understood by the personnel being trained (21 CFR 112.21(c)). Your employees stated that (b)(4). Your supervisor did not demonstrate a means to communicate with employees in order to correct their food handling practices. Further, farm management stated that they have not successfully completed a food safety training at least equivalent to that received under a standardized curriculum recognized as adequate by the FDA, as required by 21 CFR 112.22(c). This deviation from the PSR was observed during a previous inspection of your firm conducted October 2-10, 2019."
5. "Personnel at your firm did not use hygienic practices, as required by 21 CFR 112.32. Specifically:
1. On May 23 and 24, 2022, four (4) employees handled sprouts without first washing their hands before donning single-use gloves when returning from break or handled sprouts when gloves may have been soiled.
2. On May 24, 2022, employees handled the bottom of a bin kept on the floor and then handled sprouts without washing their hands or changing gloves.
3. On May 24, 2022, a gloved employee picked up a hose lying on the floor, used the hose, and then rinsed their gloved hands with only water in the production room hand sink before returning to the production line to skim mung bean sprout particles from the production line water bath.
4. On May 23, 2022, two employees were packaging sprouts wearing watches that were not covered by their gloves or clothing. An employee was wearing a dangling necklace while packaging sprouts."

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/happy-sprout-inc-638237-10272022
WARNING LETTER

Happy Sprout Inc.
MARCS-CMS 638237 — OCTOBER 27, 2022
Recipient:
Hyo Young Lee
Owner
Happy Sprout Inc.
7954 Twist Lane, Unit H
Springfield, VA 22153-2823
United States

A Meat-alternative Plant Receives Scrutiny After Employee Leaks Information to Press

An employee leaked information and pictures to a news reporter regarding unsanitary conditions at facility that produces alternative-meat products.  Listeria-testing data indicated a high prevalence of Listeria in the facility, which may not be overly surprising for a facility that was once a meat operation until it was purchased to produce meat-alternative products.  While the meat-alternative products are not RTE, that is, they will be cooked, one would not expect to see this level considering the ingredients used to make the meat-alternative product.  Couple this with unsanitary procedures creates a higher risk status for the consumer.

"In a response to Bloomberg, Beyond pointed out that the plant had passed inspections by both state and federal authorities. Bloomberg, however, stated that the state “inspection” was a routine annual visit that did not include a comprehensive examination of food safety, and that the USDA said it hadn’t inspected the plant since Beyond bought it."

Food Processing Magazine
https://www.foodprocessing.com/food-safety/cleaning-sanitation-hygiene/news/21438201/report-beyond-meat-plant-had-sanitation-problems
Report: Beyond Meat Plant Had Sanitation Problems
Nov. 22, 2022

Ice Cream Recalled After Packaging Error Results in Undeclared Allergens

Weis Markets today said it has issued a recall for 108 containers of Weis Quality Sea Salt Caramel Ripple Ice Cream (48oz) since the product may contain undeclared soy and coconut allergens.  The recall was initiated after it was discovered that product containing soy and coconut was distributed in packaging that did not reveal the presence of soy and coconut. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company’s production and packaging process.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/weis-markets-issues-allergy-alert-weis-quality-premium-sea-salt-and-caramel-ripple-ice-cream-due
Weis Markets Issues an Allergy Alert for Weis Quality Premium Sea Salt and Caramel Ripple Ice Cream Due to Undeclared Soy and Coconut Allergens
Summary
Company Announcement Date:  November 23, 2022
FDA Publish Date:  November 23, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Soy and Coconut Allergens
Company Name:  Weis Markets
Brand Name:  Weis Quality
Product Description:  Premium Sea Salt and Caramel Ripple Ice Cream

QA Director Pleads Guilty to Concealing Conditions That Lead to Salmonella Outbreak Linked to Cereal

A QA Director has pleaded guilty for concealing food facility conditions that led to a Salmonella outbreak where 130 people were infected. "Ravi Chermala overlooked unsanitary conditions that led to the Salmonella outbreak linked to Kellogg's Honey Smacks cereal in 2018.

From the Justice report, "Ravi Kumar Chermala, 47, pleaded guilty to three misdemeanor counts of causing the introduction of adulterated food into interstate commerce. Chermala, Kerry’s Director of Quality Assurance until September 2018, oversaw the sanitation programs at various Kerry manufacturing plants, including a facility in Gridley, Illinois, that manufactured Kellogg’s Honey Smacks breakfast cereal for Kerry’s customer, the Kellogg Company. In pleading guilty, Chermala admitted that between June 2016 and June 2018, he directed subordinates to not report certain information to Kellogg’s about conditions at the Gridley facility. In addition, Chermala admitted that he directed subordinates at the Gridley facility to alter the plant’s program for monitoring for the presence of pathogens in the plant, limiting the facility’s ability to accurately detect insanitary conditions."

Don't be this guy.


https://www.foodprocessing.com/food-safety/news/21438121/former-kerry-qa-director-pleads-guilty-in-2018-salmonella-outbreak-from-kelloggs-honey-smacks-cereal
Former Kerry QA Director Pleads Guilty in 2018 Salmonella Outbreak
Nov. 20, 2022

Ravi Chermala overlooked unsanitary conditions that led to Kellogg's Honey Smacks cereal recall and 130 illnesses.

Just Another Recall for Enoki Mushrooms After MI Lab Detects Listeria

Green Day Produce, Inc. of Vernon, CA is recalling its 200g/ 7.05oz packages of ENOKI MUSHROOM (Product of Korea) sold from September 2022 - October 2022 because it has the potential to be contaminated with Listeria monocytogenes.  The potential for contamination was discovered after a retail sample was collected and analyzed by Michigan Department of Agriculture and Rural Development (MDARD) and revealed the presence of Listeria monocytogenes in 200g/7.05 oz. package of Enoki mushroom.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/green-day-produce-inc-recalls-enoki-mushrooms-because-possible-health-risk
Green Day Produce, Inc. Recalls Enoki Mushrooms Because of Possible Health Risk
Summary
Company Announcement Date:  November 17, 2022
FDA Publish Date:  November 17, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Potential to be contaminated with Listeria Monocytogenes
Company Name:  Green Day Produce
Brand Name:  Green Day Produce
Product Description:  Enoki Mushrooms

Wheat-free Power Pancakes Recalled for Containing 1% Wheat

Phil’s Power Pancake of Costa Mesa, CA is recalling its 5 oz. packages of individually wrapped Power Pancakes in all 5 varieties (Mango, Raspberry, Cranberry, Dates, and Chocolate Chip Hempseed) because they may contain undeclared wheat.  All 5 varieties of pancakes contain rye flour that contains 1% wheat. Labels on the product distributed state “wheat free” and new labels will read “99% wheat free”.

1) That 1% present does not allow one to say 'free' from that.

2) Power pancakes are a thing.....just have to douse them with plenty of maple syrup I guess to get them to slide on down.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/phils-power-pancake-issues-allergy-alert-undeclared-wheat-phils-power-pancake
Phil’s Power Pancake Issues Allergy Alert on Undeclared Wheat in Phil’s Power Pancake
Summary
Company Announcement Date:  November 17, 2022
FDA Publish Date:  November 18, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared wheat
Company Name:  Phil’s Power Pancake
Brand Name:  Phil’s Power Pancake
Product Description:  Pancakes in 5 varieties (mango, raspberry, cranberry, dates, chocolate chip hempseed

Australia - Poppy Seed Mix-up Results in Illness as People Consume Poppy Seed Tea Containing Seeds Grown for Medicine

In Australia, 19 people suffered toxic contamination after drinking poppy seed tea.  The poppy seeds in the product contained non-food-grade seeds that were grown for their medical attributes, namely they contain high amounts of the controlled drug thebaine.

As you may know, poppy seeds come from the poppy flower, which is the source of the narcotic drug opium which is used to produce painkillers like morphine and codeine.  "Australia is one of the largest global producers of poppy seeds, with Tasmania at one point estimated to have supplied half of global stocks.  The crop is tightly controlled, because the plant's capsules can be deadly if ingested. Overdoses from drinking poppy have been fatal."

https://www.abc.net.au/news/2022-11-16/poppy-seed-warning-recalled-thebaine-toxic-tea-opiates/101659048
There is a nationwide recall of toxic poppy seeds. What is thebaine? And how do you get sick from poppy seeds?
Posted Tue 15 Nov 2022 at 9:24pmTuesday 15 Nov 2022 at 9:24pm, updated Wed 16 Nov 2022 at 6:04pm

Tyson Recalls 50 Tons of Ground Meat After Complaints of Mirror-like Foreign Material

Tyson Fresh Meats, Inc., an Amarillo, Texas establishment, is recalling approximately 93,697 pounds of raw ground beef products that may be contaminated with extraneous materials, specifically reflective mirror-like material.  The problem was discovered when the firm notified FSIS that they received consumer complaints reporting findings of “mirror-like” material in ground beef products purchased from grocery stores.  There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

https://www.fsis.usda.gov/recalls-alerts/tyson-fresh-meats-inc--recalls-raw-ground-beef-products-due-possible-foreign-matter
Tyson Fresh Meats, Inc. Recalls Raw Ground Beef Products Due to Possible Foreign Matter Contamination
TYSON FRESH MEATS, INC.

FSIS Announcement

WASHINGTON, Nov. 16, 2022 – Tyson Fresh Meats, Inc., an Amarillo, Texas establishment, is recalling approximately 93,697 pounds of raw ground beef products that may be contaminated with extraneous materials, specifically reflective mirror-like material, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

NY Firm Recalls Fudge After Packaging Mix-up Results in Undeclared Walnuts

Fudgeamentals of Melville, New York has voluntarily recalled one lot of Chocolate Fudge Bites packaged in 8 oz. plastic containers. The Chocolate Fudge Bites products may contain Chocolate Walnut Fudge Bites products instead, resulting in the presence of undeclared tree nut (walnut) ingredient.  The issue was discovered after one of the store employees discovered Chocolate Walnut Fudge Bites were incorrectly labeled as Chocolate Fudge Bites.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fudgeamentals-recalls-chocolate-fudge-bites-because-undeclared-walnuts
Fudgeamentals Recalls Chocolate Fudge Bites Because of Undeclared Walnuts
Summary
Company Announcement Date:  November 17, 2022
FDA Publish Date:  November 17, 2022
Product Type:  Food & Beverages  Chocolate/Cocoa Product
Reason for Announcement:  Undeclared walnuts
Company Name:  Fudgeamentals
Brand Name:  Fudgeamentals
Product Description:  Chocolate fudge bites

Closure of Local Pizza Shop Gains Media Attention

Canyon Pizza has been a State College staple for late night pizza since 2001. Not necessary an award winning pizza, but with its large pies and cheap price, it have endured the ever changing restaurant scene in this college town. After an inspection by the local health authority this week, however, it received a lot of press, although not the good kind.

The inspection noted 13 violations.  None by itself that would store-closing, but in total, it paints the picture of a dirty operation, one that is definite need of a good scrubbing and repair.  How did it get to this point?  Didn't management look closely and think that things are not as they should be?  Why do some have to wait until an inspection in order to do the necessary work?  And now, to have the brand damaged for all to see.

PDA website for results of restaurant inspections
https://www.pafoodsafety.pa.gov/Web/Inspection/PublicInspectionSearch.aspx

4 - 301.14 Explain Code Submit
Inspector Comments
--Hood system is not adequate to remove heat and/or grease, as evidenced by condensate and/or grease collecting on the walls, ceilings, and fixtures. Hood is in need of a professional cleaning as required by the Centre Region Property Maintenance Code.

Ending the Thanksgiving Meal Controversies

Thanksgiving.   A time to gather with family and friends.  A time to feast.   A time to time to argue….umm….converse about important stuff ...like stuffing. Indeed, there are some age-old controversies surrounding the Thanksgiving meal.  Questions such as.....Is it stuffing or is it dressing? ......White meat vs dark meat? ......What is the best temperature for cooking the turkey?

To help foster a harmonious atmosphere during your holiday gathering, we will provide you with some next-level input for resolving these questions. We have assembled a Blue Ribbon Panel….Yes, I know what you are thinking….really, a Blue Ribbon Panel? Yes, a Blue Ribbon Panel indeed and that means this s**t is about to get serious. The make-up of this esteemed panel includes the tri-country turkey basting champion from Rebersburg PA, a state inspector from the top turkey-growing state of Minnesota (I too thought it was North Carolina…I guess the frigid weather saves on freezing costs), a decorated Blue Ribbon Panelist from Shickshinny, PA who has served on over 30 Blue Ribbon Panels, a faculty member who did not want to share NIL information (name, image, likeness) without proper compensation, a bearded guy named Jeb, and a few others who were loitering in the hall. 

They are ready, so let’s get on to it.

Stuffing vs Dressing? Some call it stuffing. Some call it dressing. Some people say it depends on whether it is in the bird, stuffing, or cooked as a casserole, dressing. However, it is the same stuff, regardless.  What you call it depend on where you are from….a regional thing. So to settle this, we go to a source that knows no boundary….Walmart. We took a look at the bags of product sold at Walmart (including Martin’s Stuffing Cubes and Pepperidge Farms Stuffing Mix) and what do you notice….these bags are labeled stuffing. And the listed directions do not have different names for how it is made….that is, whether making it inside the bird or doing it straight up in the casserole dish, they call it stuffing. 

Blue Ribbon Panel – Stuffing.

FDA Rolls Out Traceability Rule as Part of FSMA Regulations

FDA released (11/15/22) their latest rule, Food Traceability as a means to allow for faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths.  (https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods)

Basically, if the food item is on the FTL, the Food Traceability List, there are traceability requirements.

The items that are currently on the list (below) require a Food Traceability Plan (except for those where there is an exemption)

1. A description of the procedures you use to maintain the records you are required to keep under this subpart, including the format and location of these records. 
2. A description of the procedures you use to identify foods on the Food Traceability List that you manufacture, process, pack, or hold; 
3. A description of how you assign traceability lot codes to foods on the Food Traceability List in accordance with § 1.1320, if applicable; 
4. A statement identifying a point of contact for questions regarding your traceability plan and records; and 
5. If you grow or raise a food on the Food Traceability List (other than eggs), a farm map showing the areas in which you grow or raise such foods. 
• Except as specified in paragraph (a)(5)(ii) of this section, the farm map must show the location and name of each field (or other growing area) in which you grow a food on the Food Traceability List, including geographic coordinates and any other information needed to identify the location of each field or growing area.
• For aquaculture farms, the farm map must show the location and name of each container (e.g., pond, pool, tank, cage) in which you raise seafood on the Food Traceability List, including geographic coordinates and any other information needed to identify the location of each container

You must update your traceability plan as needed to ensure that the information provided reflects your current practices and to ensure that you are in compliance with the requirements of this subpart. You must retain your previous traceability plan for 2 years after you update the plan.

Specific records (KDE) must be kept for each Critical Tracking Event (CTE) -  harvesting, cooling, initial packing, shipping, receiving, and transforming the product.

There is more information summarized on the FDA website for what needs to be recorded for each of the steps (below)  However, one can expect that most processors will already have the required tracking systems in place including lot coding.  So the KDEs for the CTL of Transformation (processing).

Transformation KDEs  (Key Data Elements)

FTL food(s) used as ingredient(s)

KDEs must be linked to the new traceability lot for the food

• Traceability lot code for the food

• Product description for the food to which the traceability lot code applies

• For each traceability lot used, the quantity and unit of measure of the food used from that lot

Transformation KDEs for New food produced

KDEs must be linked to the new traceability lot for the food

• New traceability lot code for the food

• Location description for where you transformed the food (i.e., the traceability lot code source), and (if applicable) 

the traceability lot code source reference

• Date transformation was completed

• Product description for the food

• Quantity and unit of measure of the food

• Reference document type and reference document number

So for the the items on the FTL, you will need KDEs for each of the CTLs  (oh brother).

So what items are on the FTL for now. (And items can be added to this list over time by FDA)

FDA Warning Letter Issued to Bakery for Lack of Allergen Preventive Controls

FDA issued a Warning Letter to a Chicago bakery, Third Synthesis Inc., dba Chicago Sweet Connections, Inc..  FDA determined that the ready-to-eat (RTE) cakes and paczkis manufactured in the facility were adulterated within the meaning of the regulation because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule. 

The facility did not consider allergens a significant hazard within the food safety plan although the "facility receives, stores, and uses allergens such as wheat, milk, egg, soy, and tree nuts (including walnuts, pecans, and coconut) in production." FDA concluded "Therefore, undeclared allergens are a known or reasonably foreseeable hazard. Further, a knowledgeable person manufacturing/processing food in your circumstances would identify undeclared allergens as a hazard requiring a preventive control."  Further, "Furthermore, as mentioned above, FDA investigators observed several types of paczkis and coffee cakes which did not declare allergens, including wheat, milk and/or egg."

Another issue with the Food Safety Plan was not utilizing a Sanitation Preventive Control for pathogens in post-process environment.  The report also criticizes the plan development for not identifying mycotoxins as a hazard in the hazard analysis.

There were also a number of label design issues that resulted in a number of products being mislabeled.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/third-synthesis-inc-dba-chicago-sweet-connections-inc-633453-09062022
Third Synthesis Inc., dba Chicago Sweet Connections, Inc.
MARCS-CMS 633453 — SEPTEMBER 06, 2022

Recipient:
Anthanasios Kailis
President/CEO/Owner
Third Synthesis Inc., dba Chicago Sweet Connections, Inc.
5569 N. Northwest Highway
Chicago, IL 60630
United States

The Importance of Reanalysis of the Food Safety Plan

An article in Food Safety Magazine discusses the importance of conducting the reanalysis of the food safety plan.  For many organizations, the reanalysis process is put off until the time it is required to be completed.  Rather, it should be an active process that is ongoing with specific triggers, including process change or failure, complaint data, or industry developments.

https://www.food-safety.com/articles/8051-reanalysisa-critical-component-of-verification
Reanalysis—A Critical Component of Verification

The Food Safety Plan/HACCP Plan is a living document that requires ongoing maintenance, including reanalysis at appropriate time intervals

CDC Investigating a Listeria Outbreak Linked to Deli meat and Cheese

CDC is investigating an Outbreak of Listeria linked to deli meat and cheese. There have been 16 illnesses and 1 death from 6 states, with NY showing the highest level (7 cases).  " Sick people range in age from 38 to 92 years, with a median age of 74, and 62% are male. Of 13 people with ethnicity information available, 11 are of Eastern European background or speak Russian. Of 14 people with information available, 13 have been hospitalized, including one Maryland resident who died. One person got sick during their pregnancy, resulting in pregnancy loss."

"In 2021, health officials in New York state and New York City found the outbreak strain of Listeria in several environmental and food samples: 1) Environmental samples from a NetCost Market deli in Brooklyn, 2)Several open packages of mortadella and ham that were sliced at the same NetCost Market deli in Brooklyn and 3) Sliced salami that a sick person bought from a NetCost Market deli in Staten Island.  In September 2022, the outbreak strain was found at the same Brooklyn NetCost Market deli; however, the most recent illness with NetCost Market exposure was in October 2021. After a deep cleaning, additional environmental testing did not identify Listeria in the deli."

https://www.cdc.gov/listeria/outbreaks/deli-11-22/index.html
Listeria Outbreak Linked to Deli Meat and Cheese
Fast Facts
Illnesses: 16
Hospitalizations: 13
Deaths: 1
States: 6
Recall: No

Non-Federally-Inspected CA Establishment Recalls Beef Dumplings

Menu19 LLC, a Modesto, Calif. establishment, is recalling approximately 5,001 pounds of frozen beef dumpling products that were produced without the benefit of federal inspection. The product subject to recall does not bear the USDA mark of inspection because Menu19 LLC is not a federally inspected establishment. These items were shipped to restaurants and retail locations in California. The problem was discovered during routine FSIS surveillance activities in retail stores when it was determined that the Mantu beef dumpling products did not have the USDA mark of inspection and were produced in an establishment that was not inspected by USDA.

https://www.fsis.usda.gov/recalls-alerts/menu19-llc-recalls-frozen-beef-dumpling-products-produced-without-benefit-inspection
Menu19 LLC Recalls Frozen Beef Dumpling Products Produced Without Benefit of Inspection

FSIS Announcement

WASHINGTON, Nov. 9, 2022 - Menu19 LLC, a Modesto, Calif. establishment, is recalling approximately 5,001 pounds of frozen beef dumpling 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.

IA Company Recalls Granola Product Due to Undeclared Milk

Big Sky Bread Company of Urbandale, IA is recalling their Big Sky Chocolate Chunk Granola and Big Sky Chocolate Chunk Peanut Butter Chip Granola because it may contain undeclared milk.  The recall was initiated after it was discovered during a routine inspection that a product containing milk was distributed in packaging that did not reveal the presence of milk.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/big-sky-bread-company-issues-allergy-alert-undeclared-milk-chocolate-chunk-granola-and-chocolate
Big Sky Bread Company Issues Allergy Alert on Undeclared Milk in Chocolate Chunk Granola and Chocolate Chunk Peanut Butter Chip Granola
Summary 
Company Announcement Date:  November 09, 2022
FDA Publish Date:  November 14, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared milk
Company Name:  Big Sky Bread Company
Brand Name:  Big Sky Bread Company
Product Description:  Chocolate Chunk Granola and Chocolate Chunk Peanut Butter Chip Granola

Whole Food Supplier Recalls Crumb Cakes Due to Undeclared Pecans

BOSTON BAKING, Inc. of Boston, MA, is recalling its 3-ounce, individually wrapped packages "Boston Baking Mini Cinnamon Crumb Cakes" food snacks sold exclusively at Whole Foods Market stores because they may contain undeclared pecans.  The recall was initiated after it was discovered by Whole Foods Market team member that the pecan-containing product was distributed in packaging that did not include pecans in the ingredient list. Subsequent investigation indicates the problem was caused by an isolated error in the company's production and packaging processes.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/boston-baking-issues-allergy-alert-undeclared-pecans-boston-baking-mini-cinnamon-crumb-cakes
Boston Baking Issues Allergy Alert on Undeclared Pecans in "Boston Baking Mini Cinnamon Crumb Cakes"
Summary
Company Announcement Date:  November 14, 2022
FDA Publish Date:  November 14, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared pecans
Company Name:  Boston Baking, Inc.
Brand Name:  Boston Baking
Product Description:  Mini Cinnamon Crumb Cake

RTE Smoked Salmon Recalled After Sample Tests Positive for Listeria

Seven Seas International USA, LLC of St. Petersburg, Florida is voluntarily recalling 540 cases of Giant Food Private Label Sockeye Smoked Salmon, because it has the potential to be contaminated with Listeria monocytogenes.  The product was distributed by Giant Food in Maryland, Virginia, Washington D.C. and Delaware.  The issue was discovered through routine regulatory testing conducted by the Maryland Department of Health.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/seven-seas-international-usa-llc-voluntarily-recalls-giant-food-private-label-wild-caught-alaskan
Seven Seas International USA, LLC Voluntarily Recalls Giant Food Private Label Wild Caught Alaskan Sockeye Smoked Salmon Because of Possible Health Risk
Summary
Company Announcement Date:  November 08, 2022
FDA Publish Date:  November 08, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Potential Listeria monocytogenes contamination
Company Name:  Seven Seas International USA, LLC
Brand Name:  Giant
Product Description:  Smoked Salmon

Marshmallow Cookies Recalled After Routine Sampling Finds Salmonella Positive Sample

Comercializadora PepsiCo S. de R.L. de C.V. today issued a voluntary recall for 15.5 oz, 6 count box of Gamesa Arcoiris Marshmallow Cookies due to the potential presence of Salmonella.  The recall was initiated as the result of a routine sampling program by the company, which revealed the finished product may contain Salmonella.  The company initiated the voluntary recall on the product below out of a commitment to and concern for consumers. The product covered by this recall was distributed to warehouses in California and Texas and may have reached consumers through select retail stores.  No illnesses related to Salmonella have been confirmed to date.

Recalls like this are the reason why you need to make sure your laboratory is doing a good job by having controls in place to ensure accuracy of testing.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/comercializadora-pepsico-s-de-rl-de-cv-issues-voluntary-recall-gamesar-arcoiris-marshmallow-cookies
Comercializadora PepsiCo S. de R.L. de C.V. Issues Voluntary Recall of Gamesa® Arcoiris Marshmallow Cookies Due to Possible Health Risk
Summary
Company Announcement Date:  November 07, 2022
FDA Publish Date:  November 07, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Potential presence of Salmonella
Company Name:  Comercializadora PepsiCo S. de R.L. de C.V.
Brand Name:  Gamesa
Product Description:  Arcoiris Marshmallow Cookies

Interagency Report for 2020 on Foodborne Illness Attributed to Salmonella, E. coli O157, and Listeria monocytogenes

An interagency collaboration of FDA, CDC, and USDA, identified as IFSAC, released their yearly report on foodborne illness source attribution estimates based upon outbreak surveillance data.  The goal of this is to "provide a harmonized analytic approach for estimating foodborne illness source attribution  from outbreak data can provide consistency in the use and interpretation of estimates across public health and  regulatory agencies."

The information provides information on outbreaks caused by Salmonella, E.coli O157 and Listeria monocytogenes.

https://www.cdc.gov/foodsafety/ifsac/pdf/P19-2020-report-TriAgency-508.pdf
Foodborne illness source attribution estimates for 2020 for Salmonella, Escherichia coli O157, and Listeria monocytogenes using multi-year outbreak surveillance data, United States
The Interagency Food Safety Analytics Collaboration (IFSAC)
November 2022

IFSAC derived the estimates for 2020 using the same method used for the previous estimates, with some modifications. The data came from 1,287 foodborne disease outbreaks that occurred from 1998 through 2020 and for which each confirmed or suspected implicated food was assigned to a single food category. The method relies most heavily on the most recent five years of outbreak data (2016 – 2020). Foods are categorized using a scheme IFSAC created to classify foods into 17 categories that closely align with the U.S. food regulatory agencies’ classification needs.

Salmonella illnesses came from a wide variety of foods.
More than 75% of Salmonella illnesses were attributed to seven food categories: Chicken, Fruits, Pork, Seeded Vegetables (such as tomatoes), Other Produce (such as fungi, herbs, nuts, and root vegetables), Beef, and Turkey.
E. coli O157 illnesses were most often linked to Vegetable Row Crops (such as leafy greens) and Beef.
More than 80% of illnesses were linked to these two categories.
Listeria monocytogenes illnesses were most often linked to Dairy products, Fruits, and Vegetable Row Crops.
More than 75% of illnesses were attributed to these three categories, but the rarity of Listeria monocytogenes
outbreaks makes these estimates less reliable than those for other pathogens

Overall Key Results

FL Company Recalls Lettuce After Testing Lab Finds Potential for Salmonella

Kalera Public Limited Company (“Kalera” or the “Company”) (Nasdaq: KAL), is voluntarily recalling 633 cases of Krunch, Butter and Romaine whole head variety lettuce with lot codes 001293 and 001294 on the label and sold under the Kalera brand because it has the potential to be contaminated with Salmonella.  Kalera’s food safety testing procedures indicated the potential presence of Salmonella in some of its whole head lettuce SKUs. The Company promptly reported this issue to the FDA, and, to the Company’s knowledge, no illnesses have occurred or been reported to date.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kalera-voluntarily-recalls-fresh-lettuce-products-because-possible-health-risk
Kalera Voluntarily Recalls Fresh Lettuce Products Because of Possible Health Risk
Summary
Company Announcement Date:  November 03, 2022
FDA Publish Date:  November 03, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Salmonella
Company Name:  Kalera Public Limited Company
Brand Name:  Kalera
Product Description:  Fresh Lettuce Products

Edible Cookie Dough Recalled for Foreign Material - Soft Plastic Film

Nestlé USA is initiating a voluntary recall of a limited quantity of Edible Chocolate Chip Cookie Dough tubs from NESTLÉ® TOLL HOUSE® due to the potential presence of soft plastic film.  This voluntary recall is isolated to three batches of Edible Chocolate Chip Cookie Dough tubs from NESTLÉ® TOLL HOUSE® that were produced August 1-3, 2022. These products were distributed to retailers nationwide.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nestle-usa-announces-voluntary-recall-limited-quantity-edible-chocolate-chip-cookie-dough-tubs
Nestlé USA Announces Voluntary Recall of Limited Quantity of Edible Chocolate Chip Cookie Dough Tubs from NESTLÉ® TOLL HOUSE® Due to Potential Presence of Foreign Material
Summary

Company Announcement Date: November 03, 2022
FDA Publish Date: November 03, 2022
Product Type: Food & Beverages
Reason for Announcement: Potential for Soft Plastic Film
Company Name: Nestle USA
Brand Name: NESTLÉ® TOLL HOUSE®
Product Description: Edible Chocolate Chip Cookie Dough

Popcorn Recalled After Packaging Design Issue Has Gluten Free Statement on Product with Gluten

Cedar Creek Popcorn of Sac City, Iowa is recalling its 18 oz. Old-Fashioned Caramel Holiday Popcorn Box because the side of the box features a Gluten Free claim when there are elements with gluten contained in the product.  The recall was initiated because the Gluten Free claim on the side of the packaging did not match with the product’s ingredient label and allergen information. Procedures are being put in place to assure that food safety issues are taken into consideration for the design and approval of all future packaging.

This appears to be a packaging design issue where someone did not catch the Gluten Free statement on the side of product, although it is clearly stated in the ingredient statement.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/issue-gluten-free-labeling-cedar-creek-popcorn-box-containing-gluten
Issue With “Gluten Free” Labeling on Cedar Creek Popcorn Box Containing Gluten
Summary
Company Announcement Date:  October 28, 2022
FDA Publish Date:  November 01, 2022
Product Type:  Food & Beverages  Snack Food Item 
Reason for Announcement:  Undeclared Wheat
Company Name:  Cedar Creek Popcorn
Brand Name:   Cedar Creek Popcorn
Product Description:   Old-Fashioned Caramel Holiday Popcorn Box

FDA Warning Letters Issued to Three Importers for Lack of FSVP - Nov 1 2022

Three importers were issued Warning Letters by FDA for lacking a FSVP for imported foods.

Facema, LLC. of Laurel, MD 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 imported foods, including the following food:  Tomato sauce (with other ingredients) imported from (b)(4), located in (b)(4);  Toffee candy imported from Facema S.A. de C.V. located in Nicaragua; and 
Peanuts imported from (b)(4) located in (b)(4).
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/facema-llc-640528-10182022

ARYZ Trading, LLC of  Dearborn, MI 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, including each of the following foods:  Dried mint: imported from (b)(4)
Tahina: imported from (b)(4) Extra virgin olive oil: imported from (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aryz-trading-llc-639322-09212022

Minuti Coffee Llc, of Houston, TXdid not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1.502(a). Specifically, did not develop an FSVP for any of the foods imported, including each of the following:  a. Hot Chocolate (Cioco Delice White Chocolate), imported from Caffe Molinari S.P.A., Via Francia 20, Modena, Modena, 41122, Italy b. Decaf Coffee and Vinegar, imported from Caffe Molinari SPA, Via Manfredo Fanti 200/206, Modena, Modena, 41122, Italy
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/minuti-coffee-llc-635961-08232022

FDA Warning Letter - NC Processor of RTE Product with Listeria Issue

FDA issues a Warning Letter to Bakkavor Foods facility in Charlotte, NC, a processor of ready-to-eat (RTE) dips, soups, salad bases, burritos, entrée style meals, and seafood products.

First, this company that processes RTE foods did not recognize environmental pathogens as a significant risk requiring a Preventive Control.  From the report, the" hazard analysis for “Ready to Eat Cold Salads, Sauces, Sides, and Dressings” at various processing steps (e.g., cold mixing, filling) determined that pathogens from “Environmental Cross-contamination” is a “Hazard Not Reasonably Likely To Occur due to lack of history with Food Contact Surface contamination with Listeria spp.” You also reference “Pre-Operational and Operational Sanitation Inspections” and “Good Manufacturing Practices” as “Control Measures in place.” Your sanitation inspections and GMPs are not preventive controls."

Indeed, FDA conducted environmental sampling and found Listeria.  Also of note, based upon WGS identification, the same strains had been found in the facility in 2019....an indication that this is a persistent strain.  

"To underscore the L. monocytogenes risk in your facility: FDA’s environmental findings indicate that you have a resident strain of L. monocytogenes in your facility, as well as transient strains.

FDA laboratory analysis of environmental sample 1171734 collected on February 8, 2022, from various areas in your processing facility, including food-contact surfaces and areas adjacent to food-contact surfaces, confirmed fourteen (14) of one-hundred ten (110) environmental swabs were positive for L. monocytogenes. These locations include areas where products are exposed to the environment prior to packaging in your production room, (b)(4) room, work in progress (WIP) cooler, and (b)(4) room. This was not the first time L. monocytogenes was found in environmental samples collected at your facility."

FDA noted that the company had been finding Listeria in their testing.  However, there was insufficient corrective action taken.

FDA goes on to state, "Given the history of our findings and the presence of L. monocytogenes in your facility, we continue to be concerned about your ability to maintain a sanitary environment. Your written responses did not fully explain how you investigated the source of the resident L. monocytogenes, demonstrate that you have located and eradicated the harborage site(s), or provide supporting documentation to show implementation and verification of adequate corrections (e.g., revised Food Safety Plan or routine environmental sampling results)."

GMP issues

• "Hose nozzles, used for rinsing RTE food contact equipment, stored on the floor: in the (b)(4) area, between the (b)(4) lines in the production room, next to a trash cart in the production room, and in the kettle room."
• "Excessive condensation on the ceiling and evaporators throughout your facility directly above RTE product and food-contact surfaces, including in the WIP cooler and over unprotected, cleaned, and sanitized RTE food-contact bins in the (b)(4) washroom. Also, condensation was observed on the ceiling above the (b)(4) hopper for the (b)(4) machine where RTE (b)(4) and (b)(4) are manufactured."
• "While walking across the floor of the WIP cooler, employees splashed pooled water onto trays of in-process RTE food (prior to packaging) stored on rolling racks in the cooler. The pooled water appeared dirty and contained food residue."
• "Apparent rust on the food-contact parts of the Cheese Grinder (b)(4) and its outlet port. They also observed that the (b)(4) on the (b)(4) tumblers which hold RTE food were damaged, making them difficult to clean."
• "Apparent food residue remaining on the inside cup holder framework of the (b)(4) machine where RTE (b)(4) and (b)(4) dip are packed, as well as on the conveyor belts and framework for (b)(4) lines (b)(4), after pre-op inspection and release by quality assurance "
• "Apparent old and fresh product and black residue on the wheels of the conveyors for the (b)(4) line and the (b)(4) lines after pre-operation inspection and release by quality assurance on February 10, 2022. The wheels contact the outer/food-contact surface of the belts."

There were also issues with the Seafood HACCP plan including temperature control issues with finished product.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bakkavor-foods-usa-inc-630545-08082022
Bakkavor Foods USA Inc.

Needing to Update The Environmental Sampling Program?

A recent article in Food Safety magazine ( FDA Environmental Monitoring Tactics Have Changed—Have Yours? Bryan Armentroutasks (2022)) asks if your Environmental Sampling Program can hold up to an FDA inspection's sampling regiment. It highlights aspects of the recently updated FDA Investigation Operational Manual - Chapter 4 - Sampling, specifically from this, Section 4.3.7.7.1 Environmental Sampling.

First, one should be aware and somewhat knowledgeable about the FDA Investigations Operations Manual (IOM) and within that, Chapter 4. Sampling.

The author of the Food Safety Magazine article points out keys of what FDA within their environmental sampling regiment may do that may be different than what a company's sampling plan may do.

• "They will not tell you that they are going to sample, until they are ready to start"
• "They are going to sample food contact and indirect contact surfaces"
• "They are not going to sample floors and drains"
• "They are going to sample during production, with a target of four hours of activity after a wet clean"
• "If a positive is found, they are sending it out for identification, adding it to the U.S. Centers for Disease Control and Prevention (CDC) database, and cross-referencing for any outstanding or past food safety incidents."

This does not mean that a company needs to do exactly what FDA does.  We certainly will maintain a focus on Zones 2 to 4 as a way of understanding contaminants with the facility, and focusing on preventing contamination from getting to food contact surfaces (Zone1).  But a company needs to know that Zone 1 is not contaminated and that contamination does not leak out into the facility once production is in full swing.

Selected items from 4.3.7.7.1
INVESTIGATIONS OPERATIONS MANUAL 2022 (https://www.fda.gov/media/75243/download)

4.3.7.7.1 - Environmental Sampling

• Every effort should be made to conduct Listeria sampling when the facility has been in production for at least four hours and before any wet cleaning is performed. In instances with smaller firms that have short production periods, swabbing should be conducted during the mid to tail end of their production schedule.
• In most cases, subsamples for Salmonella will be collected from the Zones 2 – 4 (see below), concentrating primarily on Zone 2. Samples should be collected from the equipment itself, particularly equipment mounting and support structures. When targeting Listeria, swabs will be collected primarily from Zones1 and 2. Perform most of the sampling for Listeria in, on, and around food contact equipment, focusing on areas where food is exposed and being processed, particularly post-treatment/pasteurization.
• A large majority of the environmental samples collected should be taken from Zones 1 (when directed and depending on the organism in question) and 2, and to a lesser degree Zone 3 areas. Very few, if any, environmental samples should be taken from Zone 4 areas.
• Swab subsample numbers for each organism are as follows:
• For Salmonella environmental swabbing, collect at least 100 swabs/subs and ideally 300 or more
• subs
• For Listeria environmental swabbing, collect at least 50 swabs/subs and ideally 100 or more subs.

Also, there can be samples taken for food samples.

Here are the FDA Zone definitions:

IL Restaurant Norovirus Outbreak with 173 Reported Ill

McHenry County Department of Health (IL) issued their investigative report into a Norovirus outbreak associated with 173 people becoming ill.

"It could not be determined during this outbreak investigation exactly how Norovirus was introduced into the food establishment. Typically, Norovirus is introduced into a food establishment through a contaminated food product or through an ill individual. The epidemiological investigation confirmed that there were multiple food items associated with illness, and multiple sources of illness. MCDH is also aware of Norovirus infection in the community at the time of the outbreak, through investigation of an unrelated, confirmed outbreak  of Norovirus at a local school. Therefore, the likelihood a food item was received at the food establishment already contaminated with Norovirus is low, and this is unlikely to be the source  of the outbreak."

https://www.mchenrycountyil.gov/home/showpublisheddocument/109263/638024843979870000
Acute Gastroenteritis (AGE) Outbreak:
D.C. Cobb’s
McHenry, Illinois
September 2022

Investigated by:
McHenry County Department of Health
2200 North Seminary Avenue
Woodstock, Illinois 6009

LA Establishment Recalls Cooked Chicken Breast Patty Product for Extraneous Clear Hard Plastic

Foster Farms, a Farmerville, La. establishment, is recalling approximately 148,000 pounds of fully cooked frozen chicken breast patty products that may be contaminated with extraneous materials, specifically hard clear pieces of plastic.  The problem was discovered when the firm notified FSIS that it received consumer complaints reporting hard clear plastic embedded in fully cooked, frozen, breaded chicken breast patty products with a best by date of Aug. 11, 2023.

https://www.fsis.usda.gov/recalls-alerts/foster-farms-recalls-fully-cooked-frozen-chicken-patty-products-due-possible-foreign
Foster Farms Recalls Fully Cooked Frozen Chicken Patty Products Due to Possible Foreign Matter Contamination

FSIS Announcement

WASHINGTON, Oct. 29, 2022 – Foster Farms, a Farmerville, La. establishment, is recalling approximately 148,000 pounds of fully cooked frozen chicken breast patty products that may be contaminated with extraneous materials, specifically hard clear pieces of plastic, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

TX Establishment Recalls Meat-containing Potstickers That Were Repacked Without Inspection

JYC Enterprise, Inc., a Houston, Texas establishment, is recalling approximately 33,280 pounds of frozen chicken and pork potsticker 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.  The problem was discovered during routine FSIS verification activities. FSIS determined that the firm repackaged and relabeled the potsticker products without the benefit of federal inspection.

Another instance of a company repackaging meat-containing products and not getting USDA-FSIS inspection.

https://www.fsis.usda.gov/recalls-alerts/jyc-enterprise-inc--recalls-chicken-and-pork-potsticker-products-produced-without
JYC Enterprise, Inc. Recalls Chicken and Pork Potsticker Products Produced Without Benefit of Inspection

FSIS Announcement
WASHINGTON, Oct. 28, 2022 – JYC Enterprise, Inc., a Houston, Texas establishment, is recalling approximately 33,280 pounds of frozen chicken and pork potsticker 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.