FDA Warning Letter to UT Bakery Highlights Preventive Control and GMP Misses Typical for Bakery

FDA issued a Warning Letter to Salt City Baking Company of Murray, Utah,  a baking company that produces ready-to-eat (RTE) bread products.  In the Preventive Controls for Human Foods training, these topics are covered, including the need to address controls associated with exposed RTE foods.

First the company "did not conduct a hazard analysis to identify and evaluate a known or reasonably foreseeable hazard to determine whether it required a preventive control for your RTE bread products."

• Did not consider environmental pathogens, such as Salmonella, as a known or reasonably foreseeable hazard to determine whether it required a preventive control. [The] facility manufactures RTE bread products (such as White Cottage sliced bread) which are exposed to the environment after baking and handled by employees prior to packaging. 
• In addition, when contamination with environmental pathogens is a hazard requiring a preventive control, [one] must verify the effectiveness of this preventive control by performing environmental monitoring for an environmental pathogen or for an appropriate indicator organism, by collecting and testing environmental samples (see 21 CFR 117.165(a)(3)). [The company is] not performing environmental monitoring to evaluate the effectiveness of  sanitation practices regarding employee practices and cleanliness of food-contact surfaces.
• Did not consider mycotoxins as a known or reasonably foreseeable hazard to determine whether it required a preventive control. [The] bread products (such as White Cottage sliced bread) contain wheat flour, which has been associated with mycotoxins such as deoxynivalenol (DON). Therefore, contamination with mycotoxins is a known or reasonably foreseeable hazard.
• A facility that identifies raw materials and other ingredients that require a supply-chain-applied control, such as mycotoxins, must establish and implement a risk-based supply-chain program for those raw materials and ingredients (see 21 CFR 117.405(a)(1)). The supply-chain program must include using approved suppliers and conducting supplier verification activities (see 21 CFR 117.410).
• The written allergen preventive controls do not include procedures, practices, and processes for ensuring protection of food from allergen cross-contact, including during storage, handling, and use; and for food labeling to ensure the food is not misbranded 
• The written Preventive Controls document indicates that the hazard of allergen cross-contact will be significantly minimized or prevented through scheduling and segregation practices. However, the allergen preventive control procedures do not cover sesame, nor do they include preventive control management components (monitoring, verification, and corrective action) for any allergens (see 21 CFR 117.140).
• In addition, the bread products are packaged in plastic bags and then the bags are placed into a cardboard case for distribution for use by foodservice establishments. The finished product labels are applied to the outside of the cardboard case. We note that you did not have adequate controls in place for undeclared allergens regarding monitoring and verification activities.

GMP Issues

Michigan Bakery Cited by FDA for Issues with Food Safety Plan and Its Implementation

FDA issued a Warning Letter to Knickerbocker 365 Inc, a processor of ready-to-eat (RTE) breads, rolls, and buns manufacturing facility located in Madison Heights, MI.

This points out many of the same issues identified in bakery operations.

The hazard analysis did not identify and evaluate a known or reasonably foreseeable hazard to determine whether it requires a preventive control.  

• The company did not consider recontamination with environmental pathogens, such as Salmonella, at steps where your RTE breads, rolls, and buns are exposed to the environment. The RTE breads, rolls, and buns are exposed to the environment at post-baking steps (including “Cooling,” “De-panning,” “Slicing,” and “Packaging”) where they could be contaminated with environmental pathogens such as Salmonella, and do not receive a lethal treatment or otherwise include a control measure (such as formulation lethal to the pathogen) that would significantly minimize pathogens.
• The RTE breads, rolls, and buns come into direct contact with post-baking equipment, such as the “(b)(4) slicer” “the (b)(4) Slicer,” and the “(b)(4) Slicer.” However, The FDA noted that written sanitation procedures, documented on the “(b)(4) Cleaning Checklist,” for equipment used post-baking do not indicate sanitizer concentration or how to clean utensils and clean out-of-place (COP) equipment (e.g., pieces of equipment (i.e., blades) from the (b)(4) slicing machine) that are cleaned and sanitized in the (b)(4) sink.
• In addition, the  facility’s environmental testing document is not clear on the frequency of collecting environmental samples for pathogens, including Salmonella. In the “Purpose” section, the document states that “Testing is to occur at the (b)(4) procedures at (b)(4).” However, in the “Background” section, the document indicates that (b)(4) for “Salmonella sp.” will be “collected quarterly.” The “Limit and Testing occurrences” in the “Procedures” section notes testing for Salmonella “at least annually.” Furthermore, the procedure does not indicate the analytical method that will be used.
• The company did not identify and implement a supply-chain preventive control to ensure control of ingredient-related pathogens.The hazard analysis for RTE breads, rolls, and buns, “21.0 HACCP Last Revision 3/2024,” identified at receiving steps for wheat flour, whey (b)(4), egg, and walnut ingredients, pathogens as a hazard associated with these ingredients used in your RTE products. The hazard analysis further identified a supply-chain control to control the pathogen hazard. However, The company did not have a written supply-chain program covering the pathogen hazard in the referenced ingredient.
• The written allergen preventive control did not include procedures, practices, and processes for ensuring protection of food from allergen cross-contact, including during storage, handling, and use, and for food labeling to ensure the food is not misbranded

The food safety plan was not prepared, nor was its preparation overseen, by one or more preventive controls qualified individual(s), as required by 21 CFR 117.126(a)(2). The hazard analysis indicates that it was approved by the President/Owner (Sandra Sokana) who is not a PCQI, and there is no PCQI trained individuals or individuals who are qualified through experience to develop and apply a food safety system.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/knickerbocker-365-inc-687624-09302024
WARNING LETTER
Knickerbocker 365 Inc.
MARCS-CMS 687624 — September 30, 2024

FDA Cites Bakery for Preventive Control and GMP Issues

FDA issued a Warning Letter to Mena Food Group, Fort Lauderdale, FL, after inspecting the facility which manufactures ready-to eat (RTE) bakery products including breads, cakes, and pastries.   The issues seen here are things that have been previously cited with other bakery operations, as well as other operations producing RTE foods.

Environmental pathogens considered a hazard requiring a preventive controls - The facility did not identify and evaluate recontamination with environmental pathogens as a known or reasonably foreseeable hazard to determine whether it requires a preventive control. The RTE bakery products are exposed to the environment at post-baking steps at the (b)(4) steps where they can be contaminated with environmental pathogens such as Salmonella and Listeria monocytogenes. The packaged bakery products do not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize pathogens. Therefore, contamination with environmental pathogens is a known or reasonably foreseeable hazard

Environmental monitoring is required - In addition, note that environmental monitoring is required if contamination of an RTE food with an environmental pathogen is a hazard requiring a preventive control (see 21 CFR 117.165(a)(3)). Your facility is not monitoring the environment for an environmental pathogen, or for an appropriate indicator organism, to verify the effectiveness of your sanitation controls.

Need to consider mycotoxins as a hazard in the hazard analysis - The facility did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control. The facility manufactures RTE bakery products (e.g., breads) containing high protein wheat flour, which has been associated with mycotoxins such as deoxynivalenol (DON). Therefore, mycotoxins are a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in your circumstances would identify mycotoxins as a hazard requiring a preventive control in this ingredient. Further, a facility that identifies raw materials and other ingredients that require a supply-chain-applied control, such as mycotoxins, must establish and implement a risk-based supply-chain program for those raw materials and ingredients (see 21 CFR 117.405(a)(1)). The supply-chain program must include using approved suppliers and conducting supplier verification activities (see 21 CFR 117.410). This program was not in place.

Allergen labeling is required - The facility’s written hazard analysis considered undeclared allergens; however, the company determined this to be the responsibility of the customer and the consumer. The  facility manufactures finished products that contain allergens such as wheat, milk, egg, soy (soybean lecithin), coconut, walnuts, and sesame. They are distributed to restaurants, hotels, nursing homes, hospitals, and distributors/wholesalers with labeling that does not include an ingredient statement and allergen declaration.  Examples - the challah burger buns, challah knot rolls, and sesame challah burger buns were staged for distribution in the staging area. They were packaged in pre-printed plastic bags without the wheat, soy, and sesame allergens declared.  The 12-inch hoagie rolls were staged for distribution in the staging area. They were packaged in clear plastic bags that did not declare wheat and soy allergens.

Allergen controls for cleaning to prevent cross contact - Allergen controls procedures for nuts do not ensure protection of food from allergen cross-contact from walnuts, as required by 21 CFR 117.135(c)(2)(i). Specifically, the hazard analysis for various RTE breads, cakes, and pastries identified the hazard of allergen cross-contact at the (b)(4) steps. At these steps, they use shared food-contact equipment and utensils to manufacture bakery products containing different allergen profiles on the same day.

The written allergen preventive control procedure states that “(b)(4)”. However, this procedure was not followed. On October 30, 2023, the rotating round turntable and utensils used by the  employee were not cleaned after handling the RTE pina colada cake (containing wheat, soy, eggs, milk and coconut) and before handling the RTE mocha cake (containing wheat, soy, eggs, and milk but not coconut).

GMP Issues

• A pastry area employee walked outside the firm to her car wearing her hairnet and plastic work apron. She returned to the pastry area without washing her hands or replacing her hairnet and plastic apron.
• A cake room employee wearing a hairnet, gloves, and plastic apron was observed preparing raw chocolate cigars. He exited the cake room door leading to the outside. A few moments later he returned through the same exterior door wearing a hairnet, gloves, apron, and the facemask. He immediately returned to preparing raw chocolate cigars without washing his hands and changing his hairnet, gloves, and plastic apron.
• A bearded pastry area employee mixing RTE frosting/icing was using his gloved hand to transfer the frosting to another bowl. While he was transferring the frosting, part of his bare arm/arm hair came in direct contact with the frosting. Also, this employee was wearing a beard cover; however, it was pulled down under his chin during the transferring of the frosting.
• In your pastry room and cake room, employees did not wash their hands or gloves after touching their face.
• Open beverage bottles were observed 1) In the bread processing area, under the preparation tables, while the employees were manipulating raw dough; 2) In the pastry area, under preparation tables, while the employees were manipulating in-process products; 3) Inside the pastry area reach-in freezer, where ingredients, in-process, and finished products are stored.
• In the cake room, your facility has a black multi-drawer toolbox where utensils (e.g., spatulas, knives, cake cutting wire) are stored after they are cleaned. These utensils are taken from the toolbox and immediately used to decorate and cut RTE cake room products. The toolbox contained personal items such as glasses, keys, and opened beverage bottles.
• The plant was not maintained  in a clean and sanitary condition and in adequate repair, as required by 21 CFR 117.35(a). Specifically: a. the fluorescent light located directly above the processing tables appeared to have a black mold-like substance on the light diffusers. Adjacent ceiling tiles were also observed with an apparent similar substance, and b. On  two large fans in the cutting and packing room were observed to have excessive filth and debris on the metal wire fan guard.  The fans were observed blowing onto RTE uncovered cupcakes on a pan rack cart.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mena-food-group-llc-673814-08082024
Mena Food Group, LLC
MARCS-CMS 673814 — August 08, 2024

Maryland Firm Recalls Tarts Due to Undeclared Almond

Atwater’s of Baltimore, MD, is recalling its clam shell packages of spider web tarts sold 10/19/24 and 10/20/24 because they contain undeclared almond flour.   The recall was initiated after it was discovered that the almond containing product was distributed in packaging that did not reveal the presence of almonds, see below for photos of both the product and packaging in question. Subsequent investigation indicated the problem was caused by a temporary breakdown in the company’s production and labeling processes.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/atwaters-issues-allergy-alert-undeclared-tree-nuts-spider-web-tart
Atwater’s Issues Allergy Alert on Undeclared Tree Nuts in “Spider Web Tart”
Summary
Company Announcement Date:  October 28, 2024
FDA Publish Date:  October 28, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Allergens
Company Name:  One Roof, LLC.
Brand Name:  Atwater’s
Product Description:  Tarts

CA Noodle Company Received FDA Warning Letter for Failure to identify Hazards and Implement Controls

FDA issues a Warning Letter to Alfred Louie Inc, a sprouting operation and noodle manufacturing facility, located in Bakersfield, CA.  The items noted in the Letter include:

• Did not conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured,
• Did not identify and evaluate allergens as a known or reasonably foreseeable hazard to determine whether allergens are a hazard requiring a preventive control.  The company processes products containing different allergen profiles on the same equipment (e.g., bowl mixer, noodle sheet maker, sheet rollers, former/cutter, and finished product conveyor) and using shared utensils on the same production day.
• Did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control. The company manufactures Pan Fry Fresh Noodles and Deep Fry Fresh Noodles products, which contain wheat flour as an ingredient. Wheat flour has been associated with mycotoxins such as deoxynivalenol (DON)
• Did not identify and evaluate metal as a known or reasonably foreseeable hazard to determine whether it requires a preventive control. Product is manufactured with processing equipment (e.g., (b)(4) noodle cutters) with metal-to-metal contact. The company does not have metal detectors and are not implementing any other programs, such as visual inspection, to control the metal hazard.
• Misbranding the finished product labels fail to accurately declare major food allergens, as required by section 403(w)(1) of the Act. 

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/alfred-louie-inc-680624-09112024
Alfred Louie, Inc.
MARCS-CMS 680624 — September 11, 2024

Florida Distributor Recalls Corn Pancakes for Undeclared Wheat

TIPICAL LATIN FOOD CORP of Miami, FL is recalling Cachapa de Maiz sweet corn pancakes labeled under Los Andes Foods, because it may contain undeclared wheat.  The recall was initiated after it was discovered that product containing wheat was distributed in packaging that did not reveal the presence of wheat. Subsequent investigation indicates the problem was caused by a labeling issue during the company's labeling process. 

On the label, flour is listed (in addition to corn flour).  The label should have identified this as wheat flour. The label was improperly designed.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tipical-latin-food-corp-issues-allergy-alert-undeclared-wheat-cachapa-de-maiz
Tipical Latin Food, Corp. Issues Allergy Alert on Undeclared Wheat in Cachapa de Maiz
Summary
Company Announcement Date:  October 11, 2024
FDA Publish Date:  October 11, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Potential or Undeclared Allergen - Wheat
Company Name:  Tipical Latin Food Corp.
Brand Name:  Los Andes Foods
Product Description:  Cachapa de Maiz sweet corn pancakes

Lancaster Country (PA) Bakery Issued Warning Letter

FDA issued a Warning Letter to McClure’s Lancaster Old Fashioned, LLC, a processor of ready-to-eat (RTE) bakery products located in Bowmansville, PA, 17507.  McClure's is a self-described Amish bakery.  (Located in the heart of Amish Country, McClures Bakery has been bringing delicious Amish baked goods to our customers for more than 50 years. The bakers at our family-owned and operated bakery specialize in making shoofly pies, cakes, bread, and other traditional recipes using the finest ingredients.)

• Did not have a hazard analysis completed for all products.
• Did not identify Salmonella as a hazard requiring a preventive control.
• Did not identify and evaluate recontamination with environmental pathogens (e.g., Salmonella and L. monocytogenes) as a known or reasonably foreseeable hazard
• did not identify and evaluate allergens as a known or reasonably foreseeable hazard to determine whether allergens are a hazard requiring a preventive control
• Duct tape is not a sanitary fix - Investigator observed production of Country Maid Creme Filled Doughnuts with Lot Code: 263 and noted duct tape at the joints of the grey PVC pipe which appeared uncleanable and was located directly above exposed creme inside the doughnut filler-hopper.
• Added allergen to Contains statement although not used in formulation - "labeling is false or misleading because “peanut” is declared in the “Contains” statements; however, “peanut” is not an ingredient in the formulations of these products. You stated that this was done as a mitigation strategy for the identified reasonably foreseeable hazard of “Allergen cross contamination.” However, FDA expects food manufacturers to follow the CGMP and PC rule to prevent the unintentional incorporation of allergens into foods which are not formulated to contain them. Labeling is not a substitute for adherence to the CGMP and PC rule. Instead, firms must comply with the applicable CGMP and PC requirements to address allergen cross-contact."
• A number of labeling-related issues.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mcclures-lancaster-old-fashioned-llc-670611-05162024
McClure’s Lancaster Old Fashioned, LLC
MARCS-CMS 670611 — MAY 16, 2024

Recipient:
Mr. Thomas Keenan
Owner & President
McClure’s Lancaster Old Fashioned, LLC
1212 Reading Road
Bowmansville, PA 17507
United States

Use of Almond Flour in Pie Instead of Wheat Flour Results in Allergic Reaction

New Seasons Market of Portland, Oregon is recalling Strawberry Rhubarb Bakewell Tart, because it contains undeclared almond. "After a staff member consumed the Strawberry Rhubarb Bakewell Tart and had a mild reaction but did not seek medical attention, the manufacturer of the product was notified of this potential allergic reaction. The manufacturer confirmed the product did contain almond flour, but almond was not listed in the product specification. New Seasons Market initiated this recall because the scale label does not declare almond."

So this appears to be a mis-formulation issue where almond flour was inadvertently used.  Also could be cross-contact where residual almond flour was not properly removed.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/new-seasons-market-issues-allergy-alert-undeclared-almonds-strawberry-rhubarb-bakewell-tart
New Seasons Market Issues Allergy Alert on Undeclared Almonds in Strawberry Rhubarb Bakewell Tart
Summary
Company Announcement Date:  June 04, 2024
FDA Publish Date:  June 04, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared almonds
Company Name:  New Seasons Market
Brand Name:  New Seasons Market
Product Description:  Strawberry Rhubarb Bakewell Tart

Warning Letter to Cookie Dough Processor Highlights FDA's Attention to Allergens and Supplier Controls

In this Warning Letter issued to a cookie dough manufacturing company, it is important to see the approach FDA is taking with regard to allergens and supplier-controlled hazards.

 Cookies-n-Milk, LLC, a processor of ready-to-eat (RTE) cookie dough located in McKinney, TX received an inspection.  The inspection was in response to using incorrect packaging, which resulted in undeclared peanut allergen in the product, as containers of Chocolate Chip Edible Cookie Dough which do not declare the allergen peanuts were filled with Peanut Butter Edible Cookie Dough which contain peanuts.  Basically, the company put peanut butter dough into chocolate chip dough containers.

First on the lack of allergen preventive controls at the labeling step.  As part of the hazard analysis, the company did not identify and determine that undeclared allergens due to incorrect labeling as a known or reasonably foreseeable hazard that requires a preventive control at the packaging/labeling step.  With that, the company did not monitor or verify that these preprinted labels are applied to the correct product during production (such as at the packaging/labeling step). The firm’s own investigation indicated that a lack of packaging controls resulted in containers of “Chocolate Chip Edible Cookie Dough,” which do not declare the allergen peanuts on the product label, being filled with Peanut Butter Edible Cookie Dough which contain peanuts

The next issue noted, and an item seen in recent Warning Letters, was the company did not identify and evaluate mycotoxins  in the incoming peanut butter as a known or reasonably foreseeable hazard to determine whether they require a preventive control. The "facility manufactures RTE edible cookie dough products containing peanut butter, which has been associated with mycotoxins such as aflatoxin. A knowledgeable person manufacturing/ processing food in your circumstances would identify mycotoxins as a hazard requiring a preventive control in peanut butter and peanut butter-containing ingredients.  With not identifying mycotoxins as a hazard requiring a preventive control, the company did not conduct supplier verification activities for mycotoxins in peanut butter and peanut butter-containing ingredients.

FDA then cited the lack of supporting documentation for corrective action as written in the company's  response to the inspection  In a response letter, the company indicated that the "dough hazard analysis will be revised to identify undeclared allergens due to mislabeling/packaging as a potential hazard with controls at packaging implemented with monitoring and verification procedures defined” and “The Edible Cookie Dough hazard analysis will be revised to identify Mycotoxins as a potential hazard for Wheat Flour and Peanut Butter with controls at the supplier level implemented with monitoring and verification procedures defined.” FDA responded, "However, the response did not contain sufficient supporting documentation for FDA to adequately evaluate your corrective actions. In addition, the response did not include a complete updated hazard analysis (to identify mycotoxins as a hazard requiring a preventive control for peanut butter and peanut butter-containing ingredients, and to identify undeclared allergens as a hazard requiring a preventive control at the packaging/labeling step) or revised food safety procedures."

WARNING LETTER
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cookies-n-milk-llc-672621-04222024
Cookies-n-Milk, LLC
MARCS-CMS 672621 — APRIL 22, 2024

FDA Cites Detroit Tortilla Baker for Inadequate Controls

FDA issued a Warning Letter to Hacienda Mexican Foods, a Detroit MI processor of ready-to-eat (RTE) soft wheat flour tortilla products.  Like so many Warning Letters recently issued, the hazard analysis  did not properly identify or evaluate all known or reasonably foreseeable hazards.  

The company "did not identify and evaluate recontamination with environmental pathogens, such as Salmonella, to determine whether it is a hazard requiring a preventive control in [the] RTE soft flour tortillas, as required by 21 CFR 117.130(a)(1). Specifically, [the] firm’s written hazard analysis did not consider the hazard of recontamination with environmental pathogens at the “(b)(4)” and “(b)(4) steps."

With that, there were inadequate sanitation controls in the post-processing environment.

Also, FDA felt that mycotoxins in incoming flour was not addressed as well as survival of pathogens in baking.

The last item is interesting.  FDA states "your food safety plan does not include written baking procedures or established parameters for baking time and/or temperature. Your firm’s Food Safety Assistant informed our investigators that your firm does not have a documented established critical limit for baking time and temperature or any validation for the adequacy of the baking process."

It did not help the firm with this statement, "you do not have controls in place to address the hazard of survival of bacterial pathogens such as Salmonella and E. coli in the baking process. While our investigators observed production of RTE soft flour tortillas, they noted that the digital temperature display for the oven did not appear to be functioning. Your firm management confirmed that it was not functioning, and it could not provide a temperature readout. Your firm’s Production Manager indicated that the digital temperature display has not functioned at any point while he had worked at your firm, which is approximately 20 years."

Finally, there are issues with the allergen preventive controls as well as a host of GMP violations.


Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hacienda-mexican-foods-llc-663221-04042024
Hacienda Mexican Foods, LLC
MARCS-CMS 663221 — APRIL 04, 2024

Colorado Noodle Company Receives FDA Warning Letter

FDA issued a Warning Letter to a Colorado based RTE noodle company for not have a food safety plan in place, and with that any of the controls needed as part of that plan.  As you may know, FDA also published another Warning Letter in this same week for a Missouri noodle company Warning Letter in this same week for a Missouri noodle company with many similar issues.  Hopefully other noodle companies are noting the coming attention and are prepared with a well written Food Safety Plan.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ng-zheng-inc-dba-kwan-sang-noodle-company-672206-04232024
Ng Zheng Inc. DBA Kwan Sang Noodle Company

FDA Issues Warning Letter to Missouri RTE Noodle Company for Many Issues

FDA issued a Warning Letter to  JX Restaurants, Inc  located in Maryland Heights, MO a manufacturer of ready-to-eat (RTE) rice and noodle-based meals and RTE rice and noodle-based under USDA jurisdiction.

This is a lengthy Warning Letter, but here are the highlights:

1. The firm did not identify and with that, have preventive controls in place for environmental pathogens including Listeria.  And as proof to this point, FDA conducted swabbing and found Listiera.

"FDA laboratory analysis of environmental sample 1216621 collected on August 9, 2023, from various areas in your processing facility during production found that eight (8) out of 111 swabs were confirmed positive for L. monocytogenes. These positive swabs were recovered in all areas of your facility including where the RTE meals are packaged, exposed to the environment, and (b)(4) by employees. Specifically, L. monocytogenes was found on a surface above your (b)(4) sink used to store utensils near the noodle and rice (b)(4) in the production area, on the wheels of multiple carts and racks located in the production area and packaging room, and the floor in the production area."

Interesting is that USDA testing had found Listeria.

"In addition, this is not the first time L. monocytogenes had been found in your facility. L. monocytogenes has also been recovered in samples collected by USDA FSIS, as follows:
May 18, 2023, your finished product, RTE Chicken Lo Mein. This product was held and not distributed to the public.
August 30, 2023, non-food contact environmental swabs collected from your facility."

This is an important point that a Preventive Controls approach forces the firm to do more in terms of controlling environmental pathogens.

2. The firm did not identify allergens as a hazard requiring a Preventive Control even though there were plenty areas for cross contact and did not follow thier own procedures for preventing allergen cross contact.

3. The firm did not recognize vegetative pathogens such as Salmonella in the raw materials, and with that, did not establish cooking as a kill step (although in making the product, they probably well exceeded the needed level.  Also, did not identify mycotoxins in wheat and peanuts.

4. Did not control chilling step.

"Your practice for chilling RTE fried rice is to spread cooked rice on a tray, which is then placed into a rolling rack. You continue to cook batches, fill trays, and load trays onto the rack to cool. Throughout the inspection, the investigator noted the ambient air temperature of the production room to be (b)(4)°F or higher."

5.  Plenty of GMP issues including employees not washing hands, poor facility cleanliness, improper cleaning of utensils, and improper use of high pressure hoses (which is a huge issue when you have Listeria contamination in the plant).

6.  Misbranding - numerous issues.

7. Reportable Food Registry - Failure to report.

"Specifically, you informed our investigator that on April 3, 2023, your customer conducted a recall on LuLu Chinese Express brand Korean Noodles with Vegetables with a Sell By date of April 11, 2023, due to an undeclared major food allergen, egg. Therefore, you became aware that the affected batches of this food contained undeclared egg on or about April 3, 2023, but you have not submitted a report to the Reportable Food Registry as of March 13, 2024".

Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jx-restaurants-inc-669669-03192024

California Bakery Cited for Failure to Comply with Any Regulations

FDA issued a Warning Letter to a California Bakery.  To make the long notice short [I really don't want to type this one out], the firm operated as if they had no knowledge of regulations.  There was no food safety plan, and with that, no controls for allergens, environmental pathogens, etc.  The firm lacked GMPs including pest control, personal hygiene, proper cleaning, etc.  They also had issues with using unapproved color additives and improper labeling.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sheng-kee-california-inc-dba-sheng-kee-bakery-668255-04242024
Sheng Kee of California, Inc dba Sheng Kee Bakery
MARCS-CMS 668255 — APRIL 24, 2024

Texas Nut Company Recalls All Products for Never Having Adhered to Allergen Regulations

Texas Pecan of Dallas TX is recalling 1 Lb and 8 oz products because it may contain an undeclared allergens - cashews, filberts, macadamias, pistachios, pecans, pine nuts, walnuts, soy, dairy (milk), sesame and wheat.

According to the company, "The problem came about with a routine check from the Texas Department of state and Health Services. When they inspected the packaging machine they decided that cross contamination was possible as our labels do states tree nut but each tree nut was not named individually. Our packaging machine is cleaned properly however our written documentation did not clearly state that."  They further state, "his company has been in business for over 40 years and no sickness or allergic reaction has ever been reported to us."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/texas-pecan-issues-allergy-alert-undeclared-tree-nuts-not-named-individually-soy-dairymilk-sesame
Texas Pecan Issues Allergy Alert on Undeclared Tree Nuts (Not Named Individually), Soy, Dairy(Milk), Sesame and Wheat Not Named in Product
Summary
Company Announcement Date:  May 08, 2024
FDA Publish Date:  May 08, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared peanut, tree nuts, soy, milk, sesame, and wheat allergens
Company Name:  Texas Pecan
Brand Name:  Texas Pecan Company
Product Description:  1 lb and 8 oz nuts, snack mixes, seeds, snack sticks

Oklahoma Flour Mill Recalls 5lb Bags of Flour Due to Undeclared Milk and Egg

Shawnee Milling Company of Shawnee, Oklahoma is recalling 5 lb.Food Club brand All Purpose Flour with Best if Used by date 03/07/2025, because it may contain undeclared milk and egg.  The recall was initiated after it was discovered by the firm that an equipment breakdown during production could have allowed allergen cross-contact.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/shawnee-milling-company-issues-allergy-alert-undeclared-milk-and-egg-5lb-food-club-all-purpose-flour
Shawnee Milling Company Issues Allergy Alert on Undeclared Milk and Egg in “5lb. Food Club All Purpose Flour”
Summary
Company Announcement Date:  March 28, 2024
FDA Publish Date:  March 29, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared milk and eggs
Company Name:  Shawnee Milling Company
Brand Name:  Food Club
Product Description:  All Purpose Flour

CA Processor of Fresh Noodle Product Issued Warning Letter for Everything...Close to Everything

FDA issued a Warning Letter to Lucky K.T. Co., Inc of El Monte, CA a processor of Fresh Rice Noodle and Rice Stick Noodle food product.

It is a huge Warning Letter, so in quick summary:

• Did not have a food safety plan with the required elements for any of the products manufactured at the  facility.
• Did not have proper controls in place for a cooked RTE product (w/pH > 4.6 and Aw close to 0.99) that could potentially support the growth of sporeforming pathogens such as B. cereus and C.botulinum.  Specifically time/temperature controls.
• Did not develop and implement controls for allergens or mycotoxins.
• A huge list of GMP violations were noted.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lucky-kt-co-inc-659663-01262024
WARNING LETTER

Lucky K.T. Co., Inc.
MARCS-CMS 659663 — JANUARY 26, 2024

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

Two Food Importers Cited for Not Having FSVP

Two food importers were issued Warning Letters for non-compliance with Foreign Supplier Verification Program (FSVP). Like many of the other importers who are sighted, these two importers did not have a program in place. As you know, the FSVP requires that companies conduct a hazard analysis for the products they import and then verify controls are in place for any identified significant hazard controlled by the foreign company.

Kyawkhin Inc., Fort Wayne, IN, 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, you did not develop an FSVP for any foods that you import, including the following foods:

• Balachong fried chili paste imported from (b)(4), located in (b)(4)
• Peanut snack imported from (b)(4), located in (b)(4)
• Cypro tone beverage base imported from (b)(4), located in (b)(4)

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kyawkhin-inc-666164-09202023

Distribuidora Jocorena Inc. Deer Park, NY did not develop an FSVP for any of the foods that you import, including the following foods:

• Pinole (corn flour) imported from (b)(4), located in (b)(4)
• Frozen corn tamale imported from (b)(4), located in (b)(4)
• Dry red beans (kidney beans) imported from (b)(4), located in (b)(4)

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/distribuidora-jocorena-inc-669434-11302023

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

Candies Containing Konjac Gum Recalled Due to Potential Choking Hazard

Tiffany Food Corp of Brooklyn, NY is recalling all codes and flavors of Mini Fruit Jelly Cups, because they may pose a choking hazard. Small jelly cups containing konjac powder have previously been implicated in choking deaths of children. Konjac and its consequent texture and consistency could pose a choking hazard to small children as well as adults with functional and/or anatomic abnormalities predisposing them to dysphagia. The potential choking hazard was confirmed after discussion with a representative from the Food and Drug Administration.

Food Additives Council
https://www.foodingredientfacts.org/facts-on-food-ingredients/sources-of-food-ingredients/konjac-gum/

• Konjac gum, or konjac flour, is a hydrocolloid (water soluble) dietary fiber derived from the Amorphophallus konjac plant (also known as devil’s tongue) that is used to provide texture, thicken, stabilize, emulsify, and suspend ingredients in foods and beverages. Konjac gum is primarily used as a source of glucomannan, which is a recognized source of dietary fiber.
• Konjac gum is safe for children in moderation and often used in medicines. However, certain forms of konjac gum have been recalled in certain countries because of the risk of suffocation from consuming large amounts due to its thickening properties. The gum runs a risk of expanding in your throat if you consume too much of it at once. This is why manufacturers adhere to regulations on the amount allowed in foods to ensure product safety.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tiffany-food-corp-recalls-mini-fruit-jelly-cups-because-possible-choking-hazard
Tiffany Food Corp Recalls Mini Fruit Jelly Cups Because of Possible Choking Hazard
Summary
Company Announcement Date:  October 19, 2023
FDA Publish Date: October 19, 2023
Product Type:  Food & Beverages
Reason for Announcement:  May pose a choking hazard
Company Name:  Tiffany Food Corp.
Brand Name:  Tiffany Food Corp.

Product Description: Mini Fruit Jelly Cups in lychee, mango and assorted flavors