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