FDA Warning Letter - Small Family-run Tortilla Company Still Does Not Have Food Safety Plan

What happens when the FDA gives you a chance to write your food safety plan and you don't do it - they issue you a Warning Letter.  Sarita's Tortilla Factory, Inc, a small company located in Eagle Pass TX had an inspection in July of 2019, during which, the company stated that they would write a Food Safety Plan.   During reinspection in July of 2021, there was no plan.   So FDA issued a Warning Letter to the company for not having a Food Safety Plan as required by regulation.

In addition, a number of GMPs were listed on the Warning Letter.  These include:

• Water was dripping from a ceiling with peeling paint onto a pallet of (b)(4)-(b)(4) bags of flour.
• Filth was present on metal air vents and fans located directly above RTE soft flour and corn tortillas.
• There were no procedures to ensure cleaning compounds and sanitizing agents are safe and adequate
• A live frog was inside the raw ingredients room, under a pallet of wheat flour. The frog was observed to enter the facility through a gap in the loading bay door.
• An unscreened door was open at the north side of the facility during the production of soft flour and corn tortillas.
• There were gaps along two screened doors located in your facility’s loading areas on the northeast side and west side of the building.
• An employee inserted an approximately 12-inch piece of splinted wood into corn tortilla dough 
• Used non-food-grade grease on tortilla production equipment.

From the company's Facebook page, it seems to be a very nice, small family run company that has been in business for at least four years.  But as we have seen with other small companies that move beyond retail sales into further distribution, they now fall under the Federal regulations. While GMPs must be adheere to for all food operations, the step up to writing and implementing a Food Safety Plan can be a challenge, but one that can be overcome, and needs to be overcome.  Or in this case, the company may file as a Qualified Facility, depending on the amount of sales. 

Sarita's Tortilla Factory, Inc - 617384 - 11/22/2021 | FDA
Sarita's Tortilla Factory, Inc

Fresh Express Recalls a Multitude of Salad Items After Testing Finds Listeria that Matches Outbreak Strain

Fresh Express is recalling certain varieties of its branded and private label salad products produced at the company’s Streamwood, Illinois facility because the product has the potential to be contaminated with Listeria monocytogenes. The recall was necessitated when the Michigan Department of Agriculture received a positive result for Listeria monocytogenes in a random sample test of a single package of Fresh Express 9 oz. Sweet Hearts salad mix with Use-By Date of December 8, 2021, manufactured at the Fresh Express Streamwood facility.

The FDA and CDC are investigating a multistate outbreak of Listeria monocytogenes infections. As of December 21, 2021, 10 people infected with the outbreak strain of Listeria monocytogenes have been reported from eight states. Illnesses started on dates ranging from July 26, 2016 to October 19, 2021.

The sample of Fresh Express Sweet Hearts salad mix with a Use-By-Date of December 8, 2021 collected and tested by Michigan Department of Agriculture and Rural Development (MDARD) tested positive for Listeria monocytogenes and subsequent whole genome sequencing (WGS) analysis determined that the Listeria monocytogenes present in the samples matches the strain that has caused illnesses in this outbreak.

Case Counts

Total Illnesses: 10

Hospitalizations: 10

Deaths: 1

Last Illness Onset: October 19, 2021

States with Cases: IL, MA, MI, NJ, NY, OH, PA, VA

Recalled Brands include - Bowl and Basket, Fresh Express, Giant Eagle, Little Salad Bar, Market District, Marketside, O Organics, Signature Farms, Simply Nature, Weis Fresh from the Field, and Wellsley Farms. Recalled salad items were distributed through retailers in the Northeast and Midwest regions of the United States, as well as distributors and retailers in Canada. U.S. distribution includes the states of CT, IA, IL, IN ,KY, MA, MD, ME, MI, MN, MO, ND, NH, NJ, NY, OH, PA, RI, WI. Canadian distribution includes the provinces of Ontario and Manitoba.

Look for codes on front of bag -  Z324 through Z350




https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresh-express-announces-recall-fresh-salad-products-due-potential-health-risk
Fresh Express Announces Recall of Fresh Salad Products Due to Potential Health Risk
Summary
Company Announcement Date:  December 20, 2021
FDA Publish Date:  December 21, 2021
Product Type:  Food & Beverages
Reason for Announcement:  Possible Listeria monocytogenes.
Company Name:  Fresh Express
Brand Name:  Fresh Express, Bowl and Basket, Giant Eagle, Marketside and Others
Product Description:  Multiple Fresh Salad Products

IFT - Food Trend Predictions for 2022

IFT published the top food industry trend predictions for 2022.  An insightful quick read.

https://www.ift.org/news-and-publications/digital-exclusives/10-food-trend-predictions-for-2022
2022 Trends
The editors at Food Technology magazine, published by the Institute of Food Technologists (IFT), have announced their predictions for the hottest food trends for 2022. Here’s what they’re forecasting for the coming year:

Fifty-one Pounds of Summer Sausage Recalled After Employee Finds Metal in Product

USDA - FSIS is issuing a public health alert for approximately 51 pounds of ready-to-eat (RTE) Hawaiian-style summer sausage products due to concerns that the products may be contaminated with extraneous materials, specifically pieces of metal.  A recall was not requested because it is believed that the products are no longer available for consumers to purchase.

https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-summer-sausage-products-due-possible-foreign-matter
FSIS Issues Public Health Alert for Summer Sausage Products Due to Possible Foreign Matter Contamination
SWISS PROCESSING PLANT INC.

WASHINGTON, Dec. 18, 2021 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert for approximately 51 pounds of ready-to-eat (RTE) Hawaiian-style summer sausage products due to concerns that the products may be contaminated with extraneous materials, specifically pieces of metal. FSIS is issuing this public health alert out of the utmost of caution to ensure that consumers are aware that these products should not be consumed. A recall was not requested because it is believed that the products are no longer available for consumers to purchase.

Wrong Packaging of Bread Lead to Recall For Unlabeled Milk Allergen

Flowers Foods, Inc. (NYSE: FLO) is voluntarily recalling 3,000 loaves of Nature’s Own Honey Wheat bread sold in six states due to the presence of undeclared milk. The recall was initiated after discovering that loaves of Nature’s Own Butterbread containing milk were inadvertently packaged in Nature’s Own Honey Wheat bread packaging, which does not include milk in the ingredient statement.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/flowers-foods-issues-voluntary-recall-limited-quantity-natures-own-honey-wheat-bread-sold-six-states
Flowers Foods Issues Voluntary Recall of a Limited Quantity of Nature’s Own Honey Wheat Bread Sold in Six States Due to the Presence of Undeclared Milk
Summary
Company Announcement Date:  December 17, 2021
FDA Publish Date:  December 20, 2021
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Milk
Company Name:  Flowers Foods, Inc.
Brand Name:  Nature’s Own
Product Description:  Honey Wheat Bread (Single and 2 Pack)

WA Bakery Recalls Bread Items for Unlabeled Allergens

Bosket Bread Company LLC of Leavenworth, Washington is recalling 54 units total of the 15 bread products, because it may contain undeclared soy, wheat, milk, sesame, or egg.  Bosket Bread’s affected products were distributed to Dan’s Food Market, Sage Mt. Foods, and Rhubarb Market in Leavenworth, WA and Wenatchee, WA.   It appears that they did not have any allergen labeling on the packages...I guess they missed the memo.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bosket-bread-company-issues-allergy-alert-undeclared-soy-wheat-milk-sesame-egg-bread
Bosket Bread Company Issues Allergy Alert on Undeclared Soy, Wheat, Milk, Sesame, Egg in Bread
Summary
Company Announcement Date:  December 18, 2021
FDA Publish Date:  December 18, 2021
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared soy, wheat, milk, sesame, or egg.
Company Name:  Bosket Bread Company
Brand Name:  Bosket Bread
Product Description:  Bread products

Pints of Butter Almond Ice Cream Pints Recalled Due to Undeclared Soy and Wheat Due to Container Mix-up

Maryland & Virginia Milk Producers Cooperative Association (MDVA) announces the immediate recall of one lot of Howling Cow Butter Almond Ice Cream Pints due to undeclared soy and wheat.  The issue was discovered when MVDA was notified by consumers that containers of the Howling Cow Butter Almond Ice Cream contained Cookie Dough Ice Cream. 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/voluntary-recall-howling-cow-butter-almond-ice-cream-due-undeclared-soy-and-wheat

Voluntary Recall of Howling Cow Butter Almond Ice Cream Due to Undeclared Soy and Wheat
Summary
Company Announcement Date:  December 11, 2021
FDA Publish Date:  December 13, 2021
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Soy, Wheat
Company Name:  Maryland & Virginia Milk Producers Cooperative Association
Band Name: Howling Cow
Product Description:  Howling Cow Butter Almond Ice Cream Pints

Pepperoni Product Recalled After Testing Finds B. cereus Issue

Smithfield Packaged Meats Corp., doing business as Margherita Meats, Inc., an Omaha, Neb. establishment, is recalling approximately 10,990 pounds of ready-to-eat (RTE) pepperoni products that may be adulterated with Bacillus cereus (B. cereus). The problem was discovered when the Department of Defense notified FSIS that they found B. cereus during routine product testing.

This is a bit interesting because one would expect to find some B. cereus in cooked meat products. B. cereus is a sporeformer and can be found in raw meat and probably more so in the spices. As a sporeformer, the spores of this organism would survive the heat processes commonly used for cooked meat products (thus the need for rapid cooling afterwards) and with pepperoni, one would not expect limited growth in the product due to antimicrobial properties (e.g., low Aw, lower pH, chemical preservatives). 

So was the number of organisms high (as determine though enumeration) or was the specification on the product tight with regard to B. cereus (absence/sample).?

https://www.fsis.usda.gov/recalls-alerts/smithfield-packaged-meats-corp.-dba-margherita-meats-inc.-recalls-pepperoni-products
Smithfield Packaged Meats Corp. Dba Margherita Meats Inc. Recalls Pepperoni Products Due To Possible Bacillus Cereus Contamination
WASHINGTON, Dec. 14, 2021 – Smithfield Packaged Meats Corp., doing business as Margherita Meats, Inc., an Omaha, Neb. establishment, is recalling approximately 10,990 pounds of ready-to-eat (RTE) pepperoni products that may be adulterated with Bacillus cereus (B. cereus), the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

MI Establishment Expands Recall of RTE Pork and Pepperoni Product For Potential Listeria Contamination Risk

Alexander & Hornung expanded their recall of fully cooked ham and pepperoni products for potential Listeria contamination.  The recall was  initially posted on Dec 5th, 2021 for 234,391 pounds of product, but now is close to ten times that amount, or 2,320,774 pounds.  The recall was first issued when  the company notified FSIS that product sampling reported positive Listeria monocytogenes results.

https://www.fsis.usda.gov/recalls-alerts/alexander-hornung-recalls-fully-cooked-pork-products-due-possible-listeria
Alexander & Hornung Recalls Fully Cooked Pork Products Due to Possible Listeria Contamination
FSIS Announcement

EDITOR’S NOTE: Dec. 11, 2021: This product recall has been expanded from 234,391 pounds to 2,320,774 pounds, with an expanded list of fully cooked ham and pepperoni products that may be contaminated with Listeria monocytogenes. The expanded list of products are highlighted in the product list found below, as well as highlighted updates to sell by dates.