FDA Warning Letter - GA Ice Cream Facility with Listeria Control Issues

FDA issued a Warning Letter to Greenwood Ice Cream, an ice cream manufacturing facility located in Chamblee, GA.

The biggest issue was inadequate control in the post-processing area where product is exposed.  As a RTE product, Listeria, as well as allergens, are a significant risk.  From the inspection notes, the company was not doing an very good job.  FDA "found that eight (8) of eighty-five (85) swabs were positive for L. monocytogenes. Of the positive findings, one (1) swab was collected from an area adjacent to food-contact surface where RTE ingredients were being prepared on the filling table. This was not the first time L. monocytogenes was found in environmental samples collected at your facility. In 2017, FDA detected L. monocytogenes in one (1) environmental swab of a floor drain, and in 2018 FDA detected L. monocytogenes in eight (8) environmental swabs, including from areas adjacent to food-contact surfaces."

On further analysis, "Whole genome sequencing (WGS) was conducted on the above referenced L. monocytogenes isolates obtained from the FDA environmental samples. Based on the results of the WGS analysis, the seventeen (17) isolates comprise three (3) different strains of L. monocytogenes. Of particular significance, fourteen (14) isolates derived from the environmental samples collected at your facility during our 2021, 2018, and 2017 inspections were genetically identical, representing a single strain of L. monocytogenes. Additionally, these fourteen (14) isolates were also genetically identical to three (3) environmental swabs collected by Georgia Department of Agriculture (GDA) during a 2016 inspection of your facility. The presence of the same strain of L. monocytogenes over multiple years is indicative of a resident pathogen or harborage site in your facility since 2016. We advised you of the importance of these WGS results via a conference call on August 3, 2021."

Along with this, there was inadequate controls for allergens, and a number of GMP issues that would have exasperated the Listeria issue.

After the Listeria outbreak associated with Blue Bell ice cream, you would think that there would be a greater level of concern for Listeria control in ice cream processing facilities. 

FDA WARNING LETTER

Greenwood Ice Cream, LLC - 616395 - 12/17/2021 | FDA
Greenwood Ice Cream, LLC
MARCS-CMS 616395 — DECEMBER 17, 2021

FDA Warning Letter - Illinois Food Repacking and Distribution Facility

FDA issued a Warning Letter to International Golden Foods, a repackaging and storage facility, located in Bensenville, IL.  The company repackages a variety of ready-to-eat (RTE) foods (e.g., tree nuts, seeds, and dried herbs and spices) and non-RTE foods (e.g., milled rice, rice flour, dried pasta, and wheat flour). The facility also stores and distributes RTE soft fresh cheeses (e.g., feta cheese and goat’s milk cheese) and pre-packaged ready-to-eat food products (e.g., tahini, grilled eggplant, pickles, dates, and figs). 

The company did not prepare, or have prepared, and did not implement a food safety plan, as required by regulation.  Preventive Controls were not in place including Allergen Preventive Controls.

From a facility and operational standpoint, there were some major issues including:

• cheeses stored at incorrect temperatures (>59F)
•  a machine used for repackaging with a cracked observation panel, a machine transfer chute made of cloth material that was not washed, and a hopper with rough seams that were discolored. 
• a live bird in your warehouse which opens directly to the repackaging room where is food is exposed. In addition, bird droppings were observed on the floor throughout the warehouse between pallets of products. 

From the company's website, we can see an importer who distributes international products.  They also repack these items to meet retail client needs.  So often we see distributors who decide to repack items without considering regulations.

FDA WARNING LETTER
International Golden Foods Inc - 619417 - 12/15/2021 | FDA
International Golden Foods Inc
MARCS-CMS 619417 — DECEMBER 15, 2021

SE PA Hepatitis Outbreak Affects 11 with One Death, Restaurant Under Investigation But Denies Involvement

The Montgomery County, PA,  Department of Health is reporting 11 cases of Hepatitis (9 confirmed) with one death.  The infections occurred in late November (it can take up to 6 weeks to see symptoms) so this makes the investigation more difficult.  

A pizzeria is being investigated as the link by the Health Department, which closed the restaurant.  The restaurant ownership denies involvement citing a clean inspection and no ill workers.

6 ABC Action News

https://6abc.com/hepatitis-a-outbreak-montgomery-county-restaurant-ginos-ristorante-west-norriton/11438258/
Montco restaurant closed amid investigation into deadly Hep A outbreak; 11 cases under investigation

Officials said 11 total cases are under investigation, with nine confirmed cases of Hepatitis A and two potential cases.

WI Establishment Recalls Snack Sticks After Packaging Label Error

Abbyland Foods, Inc., an Abbotsford, Wisc. establishment, is recalling approximately 14,976 pounds of beef sticks due to misbranding and undeclared allergens, the product contains milk, a known allergen, which is not declared on the product label.  The smoked beef sticks were produced between Nov. 15 and Nov. 17, 2021.  The problem was discovered after the firm received consumer complaints of cheese in the product and reported the event to FSIS.

So snack sticks with cheese were incorrectly labeled with the label for regular beef stick product.

https://www.fsis.usda.gov/recalls-alerts/abbyland-foods-inc.-recalls-beef-stick-product-due-misbranding-and-undeclared
Abbyland Foods, Inc. Recalls Beef Stick Product Due to Misbranding and Undeclared Allergens
FSIS Announcement

WASHINGTON, January 8, 2022 – Abbyland Foods, Inc., an Abbotsford, Wisc. establishment, is recalling approximately 14,976 pounds of beef sticks due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains milk, a known allergen, which is not declared on the product label.
The smoked beef sticks were produced between Nov. 15 and Nov. 17, 2021. The following products are subject to recall:

Extensive Salad Products Recalled After Iceberg Lettuce Harvesting Equipment Tests Positive for Listeria Monocytogenes

Dole Fresh Vegetables, Inc. is voluntarily recalling from the market all Dole-branded and private label packaged salads described below processed at its Springfield, OH and Soledad, CA production facilities containing iceberg lettuce, due to a possible health risk from Listeria monocytogenes.  This voluntary recall notification is being issued after harvest equipment used in the harvesting of the raw iceberg lettuce material used in these finished products was tested by Dole and found to contain Listeria monocytogenes.

This is a massive recall affecting product shipped all across the country and into Canada.  One would expect that this finding represents a low risk scenario. First, is the species found on the equipment a transient organism or was it part of an endemic contamination on the equipment?  With that, was the species pathogenic?  What was the level and what was the likelihood it actually contaminated product?  Was the lettuce treated afterwards in a way that would have removed surface contamination?  Was this testing part of broader Listeria investigation or was it just routine testing?


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dole-fresh-vegetables-inc-announces-voluntary-recall-certain-salads-processed-its-springfield-oh-and
Dole Fresh Vegetables, Inc. Announces Voluntary Recall for Certain Salads Processed at its Springfield, OH and Soledad, CA Facilities and Containing Iceberg Lettuce Due to Possible Health Risk from Listeria monocytogenes
Summary
Company Announcement Date:  January 07, 2022
FDA Publish Date:  January 07, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Due to a possible health risk from Listeria monocytogenes
Company Name:  Dole Fresh Vegetables, Inc.
Brand Name: Dole
Product Description:  Salads

Advent Calendar for Pets Recalled Due to Choking Hazard

ALDI in cooperation with their supplier, Pet Brands Products, LLC. are recalling Pure Being Cat Advent Calendars and Pure Being Dog Advent Calendars due to a potential choking hazard.  This comes after receiving a small number of customer complaints.  (An Advent calendar is a calendar used to count the days leading to the anticipation of Christmas.)


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/association-pet-brands-products-llc-aldi-voluntarily-recalls-pet-advent-calendars-due-potential
In Association with Pet Brands Products, LLC, ALDI Voluntarily Recalls Pet Advent Calendars Due to Potential Choking Hazard

Summary
Company Announcement Date: December 09, 2021
FDA Publish Date: January 04, 2022
Product Type: Animal & Veterinary Food & Beverages Pet Food
Reason for Announcement: Potential choking hazard
Company Name: ALDI
Brand Name: Pure Being
Product Description: Advent Calendars for Cats and Dogs
Company Announcement
Batavia, Ill. (December 9, 2021) – In cooperation with Pet Brands Products, LLC, and out of an abundance of caution, ALDI is voluntarily recalling Pure Being Cat Advent Calendars and Pure Being Dog Advent Calendars as a precautionary measure due to a potential choking hazard.

Minn Establishment Recalls Cauliflower Crust Pizza After Mistakenly Labeling Product Containing Wheat

Kettle River Products, an Askov, Minn., establishment, is recalling approximately 1,464 pounds of chicken alfredo pizza due to misbranding and an undeclared allergen - the product contains wheat, which is not declared on the product label.  The frozen, heat-treated, not fully cooked items were produced on various dates between Dec. 9, 2021 through Jan. 3, 2022. The problem was discovered when the company determined that it used labels intended for a different product that does not contain wheat and reported the issue to FSIS.

The label shown on the recall notice list a cauliflower crust (non-wheat).  And even though they have the disclaimer, "This produce is manufactured in a facility that also manufacturers that contain wheat", this does nothing.  Also important to note, that this is another 'wrong package label' recall.  In the month of December, there were 5 recalls for the same issue - putting the wrong label on a food item resulting in an allergen mismatch.

https://www.fsis.usda.gov/recalls-alerts/kettle-river-products-recalls-chicken-alfredo-pizza-products-due-misbranding-and
Kettle River Products Recalls Chicken Alfredo Pizza Products Due to Misbranding and an Undeclared Allergen

FSIS Announcement

WASHINGTON, Jan. 6, 2022 – Kettle River Products, an Askov, Minn., establishment, is recalling approximately 1,464 pounds of chicken alfredo pizza due to misbranding and an undeclared allergen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains wheat, a known allergen, which is not declared on the product label.

Oregon Meat Establishment Recalls Ground Meat After Third Party Lab Finds Pathogenic E. coli

Interstate Meat Dist. Inc., a Clackamas, Ore., establishment, is recalling approximately 28,356 pounds of ground beef products that may be contaminated with E. coli O157:H7.  The raw, ground beef items were produced on Dec. 20, 2021 and were shipped to retail locations in Arizona, California, Nevada, Oregon, Utah, Washington and Wyoming.

"The issue was reported to FSIS after a retail package of ground beef was purchased and submitted to a third-party laboratory for microbiological analysis and the sample tested positive for E. coli O157:H7. FSIS conducted an assessment of the third-party laboratory’s accreditation and methodologies and determined the results were actionable."

https://www.fsis.usda.gov/recalls-alerts/interstate-meat-dist.-inc.-recalls-ground-beef-products-due-possible-e.-coli-o157h7
Interstate Meat Dist. Inc., Recalls Ground Beef Products Due To Possible E. Coli O157:H7 Contamination

WASHINGTON, Jan. 6, 2022 – Interstate Meat Dist. Inc., a Clackamas, Ore., establishment, is recalling approximately 28,356 pounds of ground beef products that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Reportable Food Registry Dashboard - A Powerful Tool for Analysis of Hazards in the Food Supply

 FDA published their Reportable Food Registry Data Dashboard, an interactive tool to analyze data collected by the Reportable Food Registry.   FDA first rolled out the RFR in 2010, and with that data, FDA issued annual reports on hazards identified in food and feed that were reported to the agency via the electronic portal.

The Reportable Food Registry (RFR) is “an electronic portal by which reports about instances of reportable food must be submitted to FDA within 24 hours by responsible parties and may be submitted by public health officials. These reports may be primary, the initial submission about a reportable food, or subsequent, a report by either a supplier (upstream) or a recipient (downstream) of a food or food ingredient for which a primary report has been submitted.”  "Registered Food Facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States under section 415(a) of the FD&C Act (21 U.S.C. 350d) are required to report when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals."

The RFR Data Dashboard allows one to access this data to analyze particular commodities, countries of origin, and specific hazards.  There are 6 primary search headings:

• RFR Primary Entries Summary - How many entries are occurring each year with the top three commodities and top three hazards.
• RFR Primary Entries by Commodity - One can select a commodity and see the number of entries per year and hazard type of those entries, and the country where those hazards originated..  By selecting a year on the graph, one can see the hazard type or country for that given year.
• Human and Animal Food RFR Primary Entries - Allows one to see entries by human food or animal food.
• RFR Primary Entries by Hazard - here one can select a specific hazard, Pathogenic E. coli for example, and see the number of reports issued each year, the commodities involved, and the country.  Once can further select a year and see the data specific for that year.  So for the Pathogenic E. coli, there were 5 entries in 2019, and each of those entries were a different commodity item.
• Top 5 Hazards Breakdown RFR Primary Entries - allows one to look the top three hazards - Allergens, Salmonella, and Listeria by year and commodity.  In 2019 there were 56 allergen reported issues with milk and egg being the two most reported allergen types.
• RFR Primary Entries by Country - This allows one to see reports for food or feed originating out of a given country.  For example, Brazil has had 2 reports in 2019 for Salmonella, both from Animal feed/pet food.

 The RFR Dash Board (https://www.fda.gov/about-fda/fda-track-agency-wide-program-performance/fda-track-reportable-food-registry-data-dashboard) is just one of the Dashboards that one can use as part of developing their Food Safety Plan.

There is the FDA Data Dashboard (https://www.fda.gov/about-fda/transparency/fda-data-dashboard)
that allows one to search a given firm to see their inspection information. (not a bad idea to check your own firm's data to make sure it is correct).

There is the FSMA Dashboard that detail PC and GMP inspection data. https://www.fda.gov/about-fda/fda-track-agency-wide-program-performance/pc-and-cgmp-measures

https://www.fda.gov/food/cfsan-constituent-updates/fdas-faster-and-easier-reportable-food-registry-process-will-lead-better-data-and-safer-food-supply
The FDA’s Faster and Easier Reportable Food Registry Process Will Lead to Better Data and a Safer Food Supply
Constituent Update
January 5, 2022