FDA Warning Letter Focuses on Allergen Control in Mislabeling Error by Salad Dressing Company

FDA issued a Warning Letter to Simple Truths for misbranding product after a mislabeling issue resulted in a allergen related recall.  In this case, Ranch dressing containers were filled with Caesar Dressing in which case the label did not declare soy as an allergen.  The issue stated by the company occurred "because the work in progress bulk containers used to produce the recalled Plant Based Ranch Dressing were mislabeled."

FDA also found issue in the corrective action provided by the company to FDA.  In the Warning Letter, FDA states that the company's corrective action documentation indicates "that [the company] updated task instructions and will improve (b)(4) communication, limit formulation operators to pumping out (b)(4), require employees to (b)(4), and (b)(4) on the new task instructions. [The company] did not provide updated procedures, task instructions, or training records. [FDA} will verify implementation of any corrective actions during FDA’s next inspection of [the] facility."

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/litehouse-inc-662949-11292023

WARNING LETTER
Litehouse, Inc.
MARCS-CMS 662949 — NOVEMBER 29, 2023

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

Alabama Seafood Processor Recalls Crabmeat Product After Positive Listeria Testing Results

Irvington Seafood of Irvington, AL, is recalling its 1 lb. packages of "Crabmeat: Jumbo, Lump, Finger, and Claw meat" because they have the potential to be contaminated with Listeria monocytogenes,  From the report, "Kevin Sakprasit received Finish Product Testing results on May 17, 2024, at 4:31pm Central from EMSL Analytical, Inc. Crabmeat was processed on May 12, 2024, Batch #133 tested positive for L. monocytogenes. 94 samples were taken on May 13, 2024: 23 samples of Jumbo, 24 samples of Lump, 24 samples of Fingers, and 23 samples of Claw meat. Based on the lab report, 12 samples of Claw meat, and 2 samples of Fingers that were taken came back positive. "

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/irvington-seafood-recalls-crabmeat-jumbo-lump-finger-and-claw-meat-because-possible-health-risk-0
Irvington Seafood Recalls "Crabmeat: Jumbo, Lump, Finger, and Claw Meat" Because of Possible Health Risk
Summary
Company Announcement Date:  May 17, 2024
FDA Publish Date:  May 20, 2024
Product Type:  Food & Beverages  Shellfish
Reason for Announcement:  Potential Foodborne Illness - Listeria monocytogenes
Company Name:  ISF, Inc. Dba Irvington Seafood
Brand Name:  Irving Seafood
Product Description:  1 lb. packages of Crabmeat: Jumbo, Lump, Finger, and Claw meat

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

FDA Cites California Seafood Processor After Inspection Yields Listeria Positive Environmental Samples

FDA issued a Warning Letter to a California seafood processor who makes ready-to-eat (RTE) salmon and tuna.  As part of the inspection, FDA conducted sampling and analysis of the environmental samples (1195789 and 1239088) confirmed that thirty-four (34) of one hundred (100) environmental swabs were positive for pathogenic L. monocytogenes.

Further, "The analysis of the WGS data of the referenced samples showed three (3) strains of L. monocytogenes are present in your facility. Most notably, one of these strains was identified in twenty-eight (28) isolates and matched four (4) clinical isolates (2017, 2018, 2019, and 2023), indicating that this strain is known to cause human illness, however, no epidemiological data was available to link the clinical isolate to your facility."


FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ocean-group-inc-675713-04172024

Ocean Group Inc.
MARCS-CMS 675713 — APRIL 17, 2024

California Bread Company Cited for Inadequate Allergen Controls

FDA issued a Warning Letter to a California bread company after the company had a recall for undeclared allergens.   In the inspection, FDA found inadequate allergen controls. 

"Your hazard analysis for your various bread products (part of your HACCP Plan dated November 2, 2023) identified allergens as a significant hazard requiring a Critical Control Point (CCP) at the packaging/labeling step. However, your Allergens Management Program did not specifically identify the milk allergen in your sweet whey ingredient. You did not declare the milk allergen on your label for La Torta (Telera) bread products, lot # TAN NOV15, on November 2, 2023"

There were also issues with the use of Yellow No. 5.

",...the listing regulation for FD&C Yellow No. 5 requires that this certified color additive be listed as “FD&C Yellow No. 5” in the ingredient list on the labels of foods for human use that contain FD&C Yellow No. 5 [21 CFR 74.705(d)(2)]. Your Egg Bread product is manufactured with (b)(4) Egg Shade which contains FD&C Yellow No. 5; however, the label for this product fails to declare FD&C Yellow No. 5 in the ingredient statement."

There were also label misbranding issues.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/california-bread-co-674283-04252024
WARNING LETTER

California Bread Co.
MARCS-CMS 674283 — APRIL 25, 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

Recall Expanded of White-Coated Confectionary Items

More than ten days after the initial recall of white confectionary products for potential Salmonella, Palmer expanded the recall to include additional products. Palmer Candy was notified by its liquid coating supplier that there was a potential for contamination with salmonella from an ingredient that was potentially contaminated from one of their suppliers.  

So a supplier's supplier issue.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/update-palmer-candy-company-recall-white-confectionary-products-because-possible-health-risk
Update to Palmer Candy Company Recall of White Confectionary Products Because of Possible Health Risk
Summary
Company Announcement Date:  May 17, 2024
FDA Publish Date:  May 18, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Potential Contamination with Salmonella
Company Name:  Palmer Candy Company
Brand Name:  Multiple brands
Product Description:  Various Confectionary Products