TX Establishment Expands Recall of Tortillas for Undeclared Wheat and Milk

The Salsa Texan of Flower Mound, Texas is expanding an earlier recall to include all regular and burrito sized packages of tortillas labeled as Coconut Flour Tortillas and Blended Flour Tortillas because they may contain undeclared wheat and milk. The voluntary recall was initiated after it was discovered that the tortillas were distributed in packaging that did not reveal the presence of wheat or milk.  The initial recall was issued on March 18, 2022.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/salsa-texan-issues-allergy-alert-and-recall-expansion-undeclared-wheat-and-milk-tortillas
The Salsa Texan Issues Allergy Alert and Recall Expansion for Undeclared Wheat and Milk in Tortillas
Summary
Company Announcement Date:  April 15, 2022
FDA Publish Date:  April 15, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared wheat and milk
Company Name:  The Salsa Texan
Brand Name:  The Salsa Texan
Product Description:  Tortillas

Prevalence of Salmonella and Pathogenic E. coli in Raw Wheat and the Need for Control

In a recently published study, the research shows that Salmonella and pathogenic E. coli is found in raw wheat, and with that, can be found in raw flour.   A total of 5,176 wheat samples were tested for enterohemorrhagic Escherichia coli (EHEC), Salmonella spp., Listeria spp., and L. monocytogenes.

• Salmonella was in 1.23% of the samples (average level of 0.110 MPN/g), 
• EHECs occurred in 0.44% of the samples (0.039 MPN/g), 
• Listeria spp. occurred in 0.08% of samples (0.020 MPN/g), but L. monocytogenes was not detected.

A few important discussion points:

• "Contamination sources are diverse and vary with several conditions, including weather, temperature, precipitation, time of flowering, and time of harvest."   So there is no silver bullet in eliminating this contamination from getting on the raw product.
• "There are two main pathways in which the presence of pathogens in wheat flour can cause human illness: (i) by the consumption of raw dough and (ii) through cross-contamination. The widespread use of wheat products in foods and the occurrence of outbreaks associated with wheat products confirm that eating raw wheat products poses a risk for foodborne illnesses."  As processors as well as consumers, these vegetative pathogens must be considered as being potentially present, and with that, we need to have a process to eliminate the organism (baking) and procedures against cross contamination with the raw flour (cleaning).

Journal of Food Protection
https://jfoodprotection.org/doi/full/10.4315/0362-028X.JFP-18-345
Occurrence and Levels of Salmonella, Enterohemorrhagic Escherichia coli, and Listeria in Raw Wheat
Volume 82, Issue 6 (June 2019) 

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

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

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

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

MARCS-CMS 618726 — JANUARY 14, 2022

Dough Sheet Products Fail to State Wheat on the Label Resulting In Allergen Related Recall

Local Fixe LLC of Roseburg, Oregon is recalling Classic Lasagna Sheets, Soup Noodles, Dinner Rolls, Pie Dough, Squid Ink - Fettucine, and Fresh Flour Tortillas because it may contain undeclared wheat.
The recall was initiated after it was discovered that products containing undeclared wheat or gluten were distributed in packaging that did not reveal the presence of wheat or gluten. 

The ingredient statement for the Classic Lasagna Sheets states:

Ingredients: Flour, Semolina, Egg, Water

The other labels are similar in that none of them state Wheat.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/local-fixe-llc-issues-allergy-alert-undeclared-wheat-classic-lasagna-sheets-soup-noodles-dinner
Local Fixe LLC Issues Allergy Alert on Undeclared Wheat in Classic Lasagna Sheets, Soup Noodles, Dinner Rolls, Pie Dough, Squid Ink – Fettucine, and Fresh Flour Tortillas
Summary
Company Announcement Date:  December 22, 2021
FDA Publish Date:  December 22, 2021
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Wheat
Company Name:  Local Fixe LLC
Brand Name:  Local Fixe LLC

FDA Guidance to Allow Minor Label Modifications During Pandemic

The FDA issued a guidance document to provide additional temporary flexibility in food labeling requirements to manufacturers and vending machine operators.  Manufacturers can make minor formulation changes in certain circumstances without making conforming label changes, such as making a change to product ingredients, without updating the ingredient list on the packaged food when such a minor change is made.  The goal is to help move into the retail sector that was geared to go to the foodservice or other sector.
The change or modification cannot have an impact on the following:

• Safety: the change cannot affect safety, so allergens still must be correct  - "the ingredient being substituted for the labeled ingredient does not cause any adverse health effect (including food allergens, gluten, sulfites, or other foods known to cause sensitivities in some people, for example, glutamates);" 
• Quantity: The same amount must be there - "generally present at 2 percent or less by weight of the finished food;"
• Prominence: The product must still be the same - one can't label pepperoni pizza as sausage pizza - "the ingredient being omitted or substituted for the labeled ingredient is not a major ingredient in the product;"
• Characterizing Ingredient: one can't leave the pepperoni off the pepperoni pizza - the ingredient being omitted or substituted for the labeled ingredient is not a characterizing ingredient; for example, omitting raisins, a characterizing ingredient in raisin bread;"
• Claims: an omission or substitution of the ingredient does not affect any voluntary nutrient content or health claims on the label;  
• Nutrition/Function: an omission or substitution of the labeled ingredient does not have a significant impact on the finished product, including nutritional differences or functionality. 

https://www.fda.gov/food/cfsan-constituent-updates/fda-announces-temporary-flexibility-policy-regarding-certain-labeling-requirements-foods-humans
FDA Announces Temporary Flexibility Policy Regarding Certain Labeling Requirements for Foods for Humans During COVID-19 Pandemic
Constituent Update
May 22, 2020

Subway Restaurants removes dough conditioning chemical azodicarbonamide

Subway is removing azodicarbonamide, a dough conditioning chemical, from its bread formulation. This chemical can be found in bread sold by numerous retailers and foodservice establishments, however Subway was targeted because of its good nutrition stance.

FDA does allow this product to be used in bread applications. From the Code of Federal Regulations:

172.806 Azodicarbonamide.
The food additive azodicarbonamide may be safely used in food in accordance with the following prescribed conditions:
(a) It is used or intended for use:
(1) As an aging and bleaching ingredient in cereal flour in an amount not to exceed 2.05 grams per 100 pounds of flour (0.0045 percent; 45 parts per million).
(2) As a dough conditioner in bread baking in a total amount not to exceed 0.0045 percent (45 parts per million) by weight of the flour used, including any quantity of azodicarbonamide added to flour in accordance with paragraph (a)(1) of this section.
(b) To assure safe use of the additive:
(1) The label and labeling of the additive and any intermediate premix prepared therefrom shall bear, in addition to the other information required by the Act, the following:
(i) The name of the additive.
(ii) A statement of the concentration or the strength of the additive in any intermediate premixes.
(2) The label or labeling of the food additive shall also bear adequate directions for use.

 Much of the hullabaloo made is that for these reasons: 

1) the chemical is also used in non-food applications such as yoga mats……however, you can find that many chemicals used in our foods are also used in non-food applications.

2) a breakdown product of azodicarbonamide is semicarbazide, a potential hazard…… however, that is formed in the formation of plastic bottles and sealants, but any formation in bread is very low risk.

3) The chemical can be hazardous….but only in applications when working with the chemical with the potential of breathing it in in massive doses, not at 45 ppm.

Presented below are two stories, one from CNN and the other from the Huffington Post. Which one provides a more balanced view? Not CNN. As pointed out in the Huffington piece, people will not need to worry. So no need to worry, it is unlikely that Jared will have to worry about his Subway diet.

I guess this is the trend now…to identify any ingredient that has a long, unidentifiable chemical formula name and that is used in some non-food application. How about this one - dihydrogen monoxide is found in a multitude of applications, both food and non-food… including the manufacturer of cleaning compounds. Additionally, it has been involved in deaths, including a woman who died after drinking 6 liters of it in 3 hours. Time for a ban?

It is funny, on one hand, people want more government intervention into making safe food, but on the other hand, they don’t trust what the government, namely FDA and EPA, have done. 


Subway to remove 'dough conditioner' chemical from bread

By Elizabeth Landau, CNN
updated 1:23 PM EST, Thu February 6, 2014
http://www.cnn.com/2014/02/06/health/subway-bread-chemical/

(CNN) -- Take a look at ingredients for some varieties of Subway's bread and you'll find a chemical that may seem unfamiliar and hard to pronounce: azodicarbonamide.

FDA Warning Letter Issued to MA Bakery for Being Nasty

FDA issued a Warning Letter to a Massachusetts bakery, a manufacture of Peggy Lawton Ready-to-Eat (RTE) bakery products, including cookies and brownies.  It seems like this operation checked all the boxes on inspection sheet.  This operation has been operating for over 60 years doing it they way they have always done it.  A write-up in the Boston Globe discusses the company and their success and challenges.  It can be guessed that because they do not sell into larger chains, there was probably never a third party audit conducted.  Keeping low key has allowed them to stay under the radar...unfortunately for their customers.

"FDA determined that "the RTE food products manufactured in your facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions 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 (located in subparts A, C, D, E, F, and G of part 117) is prohibited by Section 301(uu) of the Act [21 USC 331(uu)]."

• No Preventive Control Plan 
• Potentially contaminating product with raw flour (which we know can contain Salmonella) -  empty bags of raw flour were observed placed over racks of ready-to-eat brownies and in direct contact with the pans of cooling brownies
• Improper maintenance - tape is not acceptable for fixes - multiple layers of electrical tape were observed wrapped around a cookie die. The cookie dough is pressed out of the die to make dough in the shape of cookies.
• Improper surfaces for holding RTE product - ready-to-eat brownies were observed placed onto mats prior to being sliced. Areas of the mats appeared to be porous, and the ends of the mats were frayed.
• Unsanitary cleaning equipment - a wire brush duct taped to a wooden pole was observed being used to remove cookie crumbs from the chain conveyor located before the first cooling tunnel. The duct tape was frayed, and there was as an accumulation of apparent food residue on the handle of the wire brush and duct tape and on the bristles of the wire brush.
• Inadequately cleaned transfer containers -  the gray totes used for holding brownie scraps were observed to have an accumulation of apparent food residue on the inside of the tote that comes into direct contact with the brownie scraps that are used to manufacture brownies.
• Non-approved sanitation chemicals and poor cleaning practices- the agent used for cleaning and sanitizing food contact surfaces consists (b)(4), Production employees were observed using this mixture of (b)(4) to wipe down food contact equipment including brownie mats, round blades for slicing brownies, brownie packing line conveyor belts, and the conveyor belts on the cookie line.
• Backflow devices needed on hoses - a hose at a two-bay sink was connected to a drum containing floor cleaner. The hose was equipped with a shut off valve where the hose connects to the drum. The hose lacked an appropriate backflow prevention device.
• Inadequate hand washing stations -  the hand washing sinks located in the cookie packing room were observed to not be operating from May 28, 2019 – May 30, 2019. Additionally, the sink located in the ingredient prep area and the sink located between the dishwasher and floor cleaner dispenser were not equipped with hand sanitizer.
• Unsanitary employee clothing - an employee working in the brownie mixing area was observed to have heavily soiled pants at the beginning of the production day (approximately 5:35 AM) and the employee’s clothing became increasingly more soiled throughout the work day. The employee's soiled pants were observed coming into direct contact with the edge of the depositor hopper each time they leaned over the brownie depositor hopper as they scraped the contents of the brownie batter mixing bowl into the depositor hopper.
• Improper sanitation procedures - the equipment used to manufacture brownie batter was cleaned with water only; the cleaning did not include the use of detergent, physical scrubbing, and a sanitizer.
• Potential cross contamination issues - an employee was observed removing sheet pans of cooked brownies and placing them on a rack immediately beneath sheets pans of uncooked brownies. Additionally, your firm uses the same oven racks for holding sheet pans of uncooked brownies prior to placing the sheet pans in the oven and for holding pans of cooked brownies after they are baked. The brownie racks, which are not placed in the oven, are cleaned every (b)(4) to (b)(4) and were observed to be soiled with apparent uncooked brownie batter and cooked brownie particles.
• Improper dishwasher usage - the dishwasher is loaded along with water and detergent at the beginning of the day. This water/detergent mixture is recycled all day and is not discharged until the end of the day. Additionally, the dishwasher does not utilize a chemical sanitizing agent. The highest temperature achieved during a complete wash cycle according to the temperature monitoring probe on the dishwasher was observed to be 142 °F.
• Inadequate hand washing by employees - numerous occasions identified where employees did not wash their hands as they should have. (see item #9)
• Probable allergen cross contact - the last batch of cookies manufactured on May 28, 2019, consisted of Chocolate Chip Cookies (which contain walnuts), and the first batch of cookies manufactured on the same equipment on May 30, 2019 (the next day of manufacturing), were Oatmeal Cookies (which do not contain walnuts). The equipment was inspected at the end of the day on May 28, 2019, but on May 30, 2019, prior to manufacturing the Oatmeal Cookies, cookie and cookie residue were observed on the chain conveyors, turn tables, cookie magazines, and cookie chutes. You stated the last time the conveyors were cleaned was January 2019.
• Improper bulk storage with the potential for contamination -  an exposed bulk size (b)(4) was observed stored on top of unopened cardboard boxes (b)(4).
• Floors inadequately cleaned and maintained - The flooring near the brownie mixing station and brownie oven was observed to have an accumulation of apparent food residue and grime after cleaning was conducted on May 29, 2019. Additionally, floor tiles were observed in disrepair with an accumulation of apparent food residue and grime in the production area.
• Standing water, a big no-no in dry operations due to microbial proliferation - Water was observed pooling over the floor drain where brownie packing operations are conducted and where employees stand and walk when packaging brownies. Additionally, pooling water was observed in an area along the wall near the shortening dispenser in the brownie batter prep area. 
• Rust and flaking paint - Paint was observed to be peeling and chipping along the wall behind the flour sifter where opened buckets of flour were held.  And the door frames to the humidifier tunnel contained apparent rust and flaking paint.
• No training records - did not have records documenting training in the principles of food hygiene and food safety for employees who manufacture, process, pack, or hold brownies

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peggy-lawton-kitchens-inc-586321-08292019

WARNING LETTER

Peggy Lawton Kitchens, Inc.
MARCS-CMS 586321 — 

August 29, 2019

Two recalls the result of metal fragment contamination

There were two recalls announced today that were both related to metal fragment contamination. One recall was packaged bagels and it was discovered due to the presence of metal fragments found in two different packages. The other was frozen pizza product. Here, small metal fragments were found in the flour. It was an ingredient issue in that the flour used to make the product had been contaminated – the third party flour mill had a faulty metal mesh screen. The fragments were reported to be too small to be detected by conventional metal detectors that were being used.

For many products, metal control is important. Too often, poorly operating metal detectors are all that stand in line for protection. Unfortunately companies may not be willing to allocate sufficient resources to buy well-built detectors or to provide proper maintenance including yearly equipment-supplier calibration. It is important that metal detectors must are properly spec’d for the type of product and process. Another important part of metal control is preventive maintenance, with a regular inspection and scheduled replacement of parts subject to operational fatigue. The cost of these recalls goes a long way against the cost of properly operating equipment.


Voluntary Regional Recall Of Thomas', Sara Lee, Publix, And Weight Watchers Bagels
http://www.fda.gov/Safety/Recalls/ucm336565.htm?source=govdelivery

FOR IMMEDIATE RELEASE - January 16, 2013 - BBU, Inc., the parent of the Bimbo Bakeries companies, has initiated a voluntary recall due to possible presence of fragments of metal caused by a faulty manufacturing part. Recalled products are the following fresh bagels with "Best Buy" dates (month and day) "JAN 18" to and including "JAN 27"found on the lock tab bag closures in the following states:

Thomas' Everything Bagels 1 lb 4 oz AL, FL, GA, TN
Thomas' Blueberry Bagels 1 lb 4 oz AL, FL, GA, TN
Thomas' Onion Bagels 1 lb 4 oz AL, FL, GA, TN
Thomas' Plain Bagels 1 lb 4 oz AL, FL, GA, TN
Thomas' Cinnamon Raisin Bagels 1 lb 4 oz AL, FL, GA, TN
Thomas' Hearty Grains 100% Whole Wheat Bagels 1 lb 4 oz AL, FL, GA, TN
Thomas' Cinnamon Swirl Bagels 1 lb 4 oz AL, FL, GA, TN
Thomas' Honey Wheat Bagels 1 lb 4 oz AL, FL, GA, TN
Sara Lee Deluxe Bagels Honey Wheat 20 oz AL, FL, GA, LA, MS, NC, SC, TN
Sara Lee Deluxe Bagels Plain 20 oz AL, FL, GA, LA, MS, NC, SC, TN
Sara Lee Deluxe Bagels Blueberry 20 oz AL, FL, GA, LA, MS, NC, SC, TN
Sara Lee Deluxe Bagels Cinnamon Raisin 20 oz AL, FL, GA, LA, MS, NC, SC, TN
Publix Premium Original Bagels 20 oz AL, FL, GA., SC, TN
Publix Premium Multi-Grain Bagels 20 oz AL, FL, GA., SC, TN
Publix Premium Cinnamon Raisin Swirl Bagels 20 oz AL, FL, GA., SC, TN
Weight Watchers 6 Original Bagels 15 oz AL, FL, GA, NC, SC, TN 

The company announced the recall after discovering metal fragments in two packages. No consumer reports have been received. There are no reports of injury.
All recalled products are being removed from store shelves. No other THOMAS', SARA LEE, PUBLIX or WEIGHT WATCHERS products are affected.

 Consumers who have purchased the product can return the product to its place of purchase for a full refund. Consumers with questions may contact the company at 1-800-984-0989 at any time 24 hours a day.



California Firm Recalls Frozen Pizzas Due To Possible Foreign Matter Contamination
http://www.fsis.usda.gov/News_&_Events/Recall_006_2013_Release/index.asp


CLASS II RECALL
HEALTH RISK: LOW

FSIS-RC-006-2013
January 23, 2013

Congressional and Public Affairs
(202) 720-9113
Richard J. McIntire

WASHINGTON, Jan. 23, 2013 – - Annie's Homegrown Inc., a Berkeley, Calif. establishment, is recalling an undetermined amount of frozen pizzas that may be contaminated with extraneous materials and are the subject of a Food and Drug Administration (FDA) recall, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today.

All varieties of "Annie's Homegrown RISING CRUST FROZEN PIZZA" with a "Best By" date including and between "09Jan13" and "14Sep13" are affected.

The following products are subject to USDA recall: [View Label]

23.6-oz. Organic Pepperoni Pizza, UPC code 0 13562 20000 9

25.4-oz. Organic Supreme Pizza, UPC code 0 13562 20002 3

22.6-oz. Pepperoni Pizza, UPC code 0 13562 20006 1

23.1-oz. BBQ Recipe Chicken Pizza, UPC code 0 13562 20009 2

Each product package above has an establishment number of "EST. 5699", "EST. 15815B", "P-5699" or "P-15815B" ink jetted on the upper flap of carton's side panel.
In addition, the following products are subject to FDA recall: 
23.5-oz. Organic Four Cheese Pizza, UPC code 0 13562 20001 6 
22.5-oz. Four Cheese Pizza, UPC code 0 13562 20007 8 
25-oz. Organic Spinach and Mushroom Pizza, UPC code 0 13562 20005 4

The products were manufactured at two facilities from May 9, 2012 to Jan. 17, 2013, and shipped to retail establishments across the United States.

The problem was discovered when metal fragments were visually detected in the flour and pizza dough at a third-party crust production facility. The problem was traced back to a defective metal mesh screen at a third party flour mill. Some wire fragments are too small to be detected by standard industry metal detectors, so it may be possible for fragments to become lodged in a finished pizza. FSIS, FDA and the company have received no reports of injury associated with consumption of these products.

FSIS routinely conducts recall effectiveness checks to verify that recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers.

Consumers with questions about the recall should contact the Annie's Homegrown Pizza hotline at (888) 825-6720. Media with questions about the recall should contact Donald C. Cutler, of Kekst & Company acting on behalf of Annie's, at (415) 852-3903.

Consumers with food safety questions can "Ask Karen," the FSIS virtual representative available 24 hours a day at AskKaren.gov or via smartphone at m.askkaren.gov. “Ask Karen” live chat services are available Monday through Friday from 10 a.m. to 4 p.m. ET. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from l0 a.m. to 4 p.m. (Eastern Time) Monday through Friday. Recorded food safety messages are available 24 hours a day. The online Electronic Consumer Complaint Monitoring System can be accessed 24 hours a day at: www.fsis.usda.gov

Ground Cricket Flour Good for Health?

Is ground cricket flour a food in your future?   There seems to be growing interest in cricket flour as a protein source and as a sustainable food.  And now there is some research to show it is good for health.  In a limited study, researchers compared a control group to a group fed cricket meal.  They saw "an increase in a metabolic enzyme associated with gut health, and a decrease in an inflammatory protein in the blood called TNF-alpha, which has been linked to other measures of well-being, like depression and cancer."

From the cricket flour web page, it takes about 5000 crickets to make a pound of cricket flour.  "Dried and roasted crickets contain an average of 55-70% protein by weight", and "includes all of the essential amino acids, B12, iron, calcium, Omega-3s and Omega-6s".  You can make cricket sausage,  cricket burgers, and cricket soup.

Is cricket flour supported by those who are against eating meat?  Interestingly, NO.  Crickets are freeze-dried to death...and then ground. (Everything but the chirp).

Are you ready to give it a try....well, you may take this advice as per a quote from a cricket - "When you meet temptation and the urge is very strong.  Give a little whistle! And always let your conscience be your guide."

Technology Networks
Eating Crickets could be Good for your Gut
News  Aug 06, 2018 | Original Story by Kelly April Tyrrell for the University of Wisconsin-Madison. 

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

FDA Issues Warning Letter to Noodle Company

FDA issued a Warning Letter to Wan-Gee Foods of St. Louis MO. The company manufacturers not-ready-to-eat noodle products (i.e., wonton wrappers, egg roll wrappers, and noodles) .

Hazard Analysis and Preventive Controls

• Did not identify Staphylococcus aureus as a hazard of concern which can be an issue if noodle dough is temperature abused.
• "Did not identify and evaluate the hazard of bacterial growth and/or toxin formation {of Staphylococcus aureus] due to lack of time/temperature control as a known or reasonably foreseeable hazard to determine whether it requires a preventive control for your canton noodles during finished product storage. The canton noodles are treated as shelf stable, stored at ambient temperatures, and are not labeled to be kept refrigerated or frozen. You do not know the water activity of the finished product canton noodles, including whether it is above 0.85."
• "did not identify and evaluate the hazard of mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control for your noodle products. The noodles contain wheat flour, which has been associated with mycotoxins such as deoxynivalenol (DON). Therefore, contamination with mycotoxins is a known or reasonably foreseeable hazard to be considered for these products."
• "did not implement your preventive controls procedures to significantly minimize or prevent contamination with the hazard of metal in your nRTE noodle products. Our investigators observed damage and missing pieces to your metal cutting blades used to shorten the dried noodles after the drying room step. The investigators requested monitoring records associated with the metal detector, but you did not provide them during the inspection."
• "written allergen preventive control does not include procedures, practices, and processes employed for labeling to ensure that all food allergens required to be stated are included on the label for your nRTE noodle products"  "procedure does not ensure all finished product labels declare all allergens present in the finished food to ensure finished food is not misbranded under section 403(w) of the Act (21 CFR 117.135(c)(2) because you do not document your review of finished product labels to ensure all allergens are properly declared."
• "do not maintain any monitoring or corrective action records of your review of your product labels to ensure the allergen ingredients are listed on the label for each batch produced. The only record you maintain for production is your mixing log and it does not include are view of the allergen ingredients in the finished food against the packaging label."

GMPs

• Black mold - "Apparent black mold formed on the ceiling directly over a drying canton noodle product in several locations throughout the room. The apparent mold covered approximately 30 percent of the ceiling. Further, the fans used to blow heated air ((b)(4) degrees Fahrenheit) directly onto the product to dry it were covered in approximately ¼ inch of apparent filth. In addition, the concrete floor along the walls in multiple locations throughout the drying room had what appeared to be white and greenish colored mold. The walls had apparent black mold in several different locations throughout the drying room."
• Product on floor - "Employee hanging noodles on racks (b)(4). During our inspection, our investigators observed the two bins separate, causing an approximate 2-to-3-in. gap in between. This resulted in the bottom quarter of the noodles coming into contact with the floor."
• Condensation - "heavily beaded condensation formed over and falling onto boxed wonton wrappers, lot number 05021168, in the blast storage freezer. Our investigators also observed condensation falling onto packaged finished product. Although the product is wrapped in wax paper, the packaging is made of thin cardboard that is not sealed and the product is susceptible to contamination while it is held overnight in the blast freezer. Our investigators observed ice formed in several other locations in the freezer, including the floor, freezer units, and walls."
• Facility issues / potential foreign objects - "brittle plastic in several areas on the tray was broken and/or frayed. (b)(4) trays being used in production were in similar condition.. Foam was present on the underside of the (b)(4) that comes indirect contact with the top layer of the wrappers during cutting. The foam is porous and not easily cleanable. Our investigators observed deteriorating foam on (b)(4) blade presses ((b)(4) egg roll and (b)(4) wonton), and parts of the foam were missing in several areas around the edges."
• Personal hygiene issues - did not take reasonable measures and precautions to ensure all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices while on duty to the extent necessary to protect again contamination of food, as required by 21 CFR 117.10(b). Specifically, on May 2, 2023, five out of ten employees were observed in street clothes covered in apparent filth while handling dough used to manufacture wonton wrappers

Wan-Gee Foods, Inc.
MARCS-CMS 660360 — NOVEMBER 09, 2023
Recipient:
Samson Wang
CEO/President
Wan-Gee Foods, Inc.
10849 Midwest Industrial Blvd.
St. Louis, MO 63132
United States

Scrapple - Pork Scrap in a Loaf....A SE PA Favorite

Scrapple....what's not to like.  A recent article reviews the long tradition of scrapple in Pennsylvania.  For those not familiar with scrapple, it is a mixture of pork scraps (every part but the oink), flour and spices.  It is made into a load by the manufacturer and then sliced and fried in oil by the consumer.  It is often served with ketchup (a lot of ketchup).

Growing up in northeastern part of the state, scrapple was not common. But for our friends in the Philly area, it is a favorite.

LNP
https://www.morningagclips.com/scrapple-is-pennsylvania-dutch-mystery-meat/
Scrapple is Pennsylvania Dutch mystery meat

Crispy on the outside and creamy on the inside, scrapple is a meaty comfort food

PUBLISHED ON October 17, 2018
ERIN NEGLEY, LNP newspaper

WA Bakery Recalls Bread for Improper Allergen Labeling

Joy Joy’s Bakery Lakewood, Washington is recalling Ube Spanish Bread, Ube Ensaymada, and Ube Roll because it may contain undeclared wheat.  The recalled products labels declared flour but it does not specify wheat flour. This labeling problem was identified by Oregon Department of Agriculture through the U. S. Food and Drug Administration.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/joy-joys-bakery-issues-allergy-alert-undeclared-wheat-ube-spanish-bread-ube-ensaymada-and-ube-roll
Joy Joy’s Bakery Issues Allergy Alert on Undeclared Wheat in Ube Spanish Bread, Ube Ensaymada, and Ube Roll
Summary
Company Announcement Date:  January 26, 2023
FDA Publish Date:  January 26, 2023
Product Type:  Food & Beverages  Bakery Product/Mix
Reason for Announcement:  Undeclared Wheat
Company Name:  Joy Joy’s Bakery
Brand Name:  Joy Joys Bakery
Product Description:  Ube Spanish Bread, Ube Ensaymada, and Ube Roll

NC Firm Recalls Spice Mixes Due to Undeclared Wheat

Vesta Fiery Gourmet Foods, Inc., of Raleigh, NC - JANUARY 8, 2024, is voluntarily recalling various  spice mixes because these products contain undeclared wheat. On 1/4/24 the firm was notified by the North Carolina Depart of Agriculture and Consumer Services that the label does not state the flour used is a wheat flour.  These products were packaged in glass jars and sold primarily online, in retail stores & deli cases located throughout the United States. Images of the products are below.

This would be a label design failure.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vesta-fiery-gourmet-foods-issues-allergy-alert-undeclared-wheat-15oz-glass-jars-benny-ts-vesta-dry
Vesta Fiery Gourmet Foods Issues Allergy Alert on Undeclared Wheat in 1.5oz Glass Jars of Benny T’s Vesta Dry Hot Sauces
Summary
Company Announcement Date:  January 08, 2024
FDA Publish Date:  January 09, 2024
Product Type:  Food & Beverages  Gravy/Sauces
Reason for Announcement:  Due to Undeclared Wheat
Company Name:  Vesta Fiery Gourmet Foods, Inc.
Brand Name:  Benny T’s
Product Description:  Benny T’s Vesta Dry Hot Sauces

NJ Importer Issued Warning Letter for Not Having FSVP

FDA issued a Warning Letter to Patidar Trade, Inc. of North Brunswick, NJ because they were in violoation fo teh Foreign Supplier Verification Program Regulation (FSVP) which requires companies to conduct a hazard analysis and enact verification procedures for items that are imported.  The comany did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, the company did not develop, maintain, and follow an FSVP for any of the imported foods including each of the following food products:

Wheat flour imported from (b)(4)

Rice flour imported from (b)(4)

Phool makhana imported from (b)(4)

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

Pillsbury Releases Raw Cookie and Brownie Dough Products that Can Safely Be Eaten Raw

General Mills and their Pillsbury division announced they their refrigerated raw cookie dough and brownie dough are now safe to eat raw (on those packages marked as such). This comes due to the "move to use heat-treated flour and pasteurized eggs, creating a unique product that families can enjoy baked or straight from the package."

Cookie and brownie dough traditionally contain flour and eggs, two raw materials that can contain microbial pathogens such as Salmonella and E. coli. These pathogens have led to cases of foodborne illness when that product was eaten raw. But by using pretreated eggs and flour, the product is designed to be safe when eaten raw, that is, before cooking by the consumer.

One of the difficulties has been creating a product where the pretreatment does not affect the functionality of the ingredients so that the product comes out the same as it did with the untreated ingredients.

General Mills
https://www.generalmills.com/en/News/NewsReleases/Library/2020/July/Pillsbury-brings-childhood-dreams-to-life
News Releases
Jul 27, 2020
Pillsbury brings childhood dreams to life: Cookie and brownie dough now ‘safe to eat raw’

Two Massive Recalls of Meat Products Due to Complaints of Foreign Material

There were two massive recalls of meat products for foreign Material this week.  In the past month, USDA has announced 5 recalls due to foreign matter contamination.

• Koch Foods, Inc., a Fairfield, Ohio establishment, is recalling approximately 119,480 pounds of beef rib-shaped patty products that may be contaminated with extraneous materials, specifically thin blue plastic pieces.  There have been no confirmed reports of adverse reactions due to consumption of these products.  The problem was discovered when the firm received notification from "a" customer,
• Conagra Brands, Inc., a Russellville, Ark. establishment, is recalling approximately 135,159 pounds of Salisbury steak products (poultry, pork, and beef) that may be contaminated with extraneous materials, specifically bone.  The problem was discovered after the firm received several consumer complaints and three reports of minor oral injury associated with consumption of this product.

The rib-shaped beef patties with thin blue plastic pieces (gloves or wrapping?) was a Class II recall and was the result of "a" complaint...so one complaint.  Back in the day, someone would just throw it out...now, a recall of 60 tons of produce, close to 3 full tractor trailer loads.  But we get it, it shouldn't be there.

The Salisbury steak recall was classified as a Class I recall since there were actual injuries.  Sounds like the bone collection system on the grinder may not have been working well enough?  (how a bone collection system works)  This recall was for 67 tons of product. Salisbury steak is that wonderful concoction of meat and other ingredients (Mechanically Separated Chicken, Pork, Water, Beef, Textured Vegetable Protein (Soy Flour, Caramel Color), Breader (Enriched Bleached Wheat Flour [Bleached Wheat Flour, Niacin, Reduced Iron, Thiamine Mononitrate, Riboflavin, Folic Acid], Durum Flour, Leavening [Sodium Bicarbonate, Sodium Acid Pyrophosphate], Yeast), 2% or less of the following: Soy Protein Concentrate, Salt, Dehydrated Onion, Caramel Color, Flavoring, Sodium Tripolyphosphate, Dextrose, Natural Flavors, Citric Acid, Soy Lecithin.) smothered with gravy.   Grill marks added for added pleasure.

So that is over 120 tons of meat product....that's a lot of meat. 

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2018/recall-032-2018-release
Koch Foods Inc. Recalls Beef Products Due to Possible Foreign Matter Contamination
Class II Recall

032-2018
Health Risk: Low 

Apr 11, 2018

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

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

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

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

FDA Issues a Warning Letter to CA Bakery for Being Nasty

FDA issued a Warning Letter to a CA bakery for, in short, being nasty.   They missed the memo that they had to comply with FDA regulations.  A problem we have seen with many smaller companies that are now required to have registered with FDA and thus are subject to FDA inspection...especially an issue among bakeries.

"..food manufactured in your facility is adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 342(a)(4)) in that it was prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth or 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 (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act (21 U.S.C. § 331(uu))." 

The inspection of the company found that they...:

• Did not have a written food safety plan.
• Did not take effective measures to exclude pests from the manufacturing, processing, packing and holding areas to protect against contamination of food on your premises by pest..had rodent excrement and insects in various places.
• Did not clean all food contact surfaces, including utensils and equipment, as frequently as necessary to protect against allergen cross-contact and against contamination
• cutting boards used to prepare products were scarred and heavily stained with a dark residue, and the plastic containers used to hold and dispense various dry ingredients were observed cracked, some being held together with blue tape,
•  ice cream scoop, used to fill lemon poppy muffins which contain almonds and wheat flour, was seen stored in a bucket of water and then used to fill gluten free muffins, which do not contain almonds or wheat flour, without being cleaned between uses
•  prepare products with raw ingredients on the same wooden table that finished products are prepared for further processing and packaging.
• The floors are not constructed in such a manner that they may be adequately cleaned and kept in good repair - specifically, during the inspection our investigators observed standing water and pitted floors with exposed aggregate, immediately adjacent to clean equipment on shelves. 
• Employees working in direct contact with food, food-contact surfaces, and food packaging materials did not conform to hygienic practices 
• Wholesale products are misbranded - the product labels fail to bear the common or usual name of the food, labels fail to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count, labels fail to include the place of business of the manufacturer, packer, or distributor, and the Lemon Poppy and Strawberry Cupcake Muffin products bear or contains a color additive which is unsafe within the meaning of section

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sweet-production-inc-578494-06172019
WARNING LETTER
Sweet Production Inc.
MARCS-CMS 578494 — Jun 17, 2019

Duncan Hines Cake Mix Recalled after Outbreak Strain Found in Product

Conagra Brands is recalling Duncan Hines cake mixes after being connected "with a positive finding of Salmonella in a retail sample of Duncan Hines Classic White cake mix that may be linked to a Salmonella outbreak", where five people have become infected.  The Salmonella strain, Salmonella Agbeni, matched the organism collected from ill persons as determined through the use of Whole Genome Sequencing.  "While it has not been definitively concluded that this product is linked to the outbreak and the investigation is still ongoing."

The baking process, if properly followed, will eliminate the organism,  However, people do eat raw batter and there is the issue of cross contamination that can occur in the kitchen when the powder mix gets onto food contact surfaces as well as other food.

Has this been an issue in the past?  Salmonella as well as STEC E. coli have been involved in flour related outbreaks and recalls (1, 2, 3 4, 5 ).  Improved techniques for tracking outbreaks and for identifying specific organisms using Whole Genome Sequencing have given a truer look at sources that may not have identified in the past.

https://www.fda.gov/Safety/Recalls/ucm625144.htm

Duncan Hines Classic White, Classic Butter Golden, Signature Confetti and Classic Yellow Cake Mixes Recalled Due to Potential Presence of Salmonella

For Immediate Release

November 5, 2018