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

Dog Food Recalled for Potential Metal Pieces in Bag

Mars Petcare US is voluntarily recalling 315 bags of PEDIGREE® Adult Complete Nutrition Grilled Steak & Vegetable Flavor Dry Dog Food in the 44 lb. bag size only, due to the potential presence of loose metal pieces in the bag.  There have been no reports of pet injury or illness regarding the potentially impacted product.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mars-petcare-us-inc-voluntarily-recalls-315-bags-pedigreer-adult-complete-nutrition-grilled-steak
Mars Petcare US, Inc. Voluntarily Recalls 315 Bags of PEDIGREE® Adult Complete Nutrition Grilled Steak & Vegetable Flavor Dry Dog Food, 44 lb. Bag Size
Summary
Company Announcement Date:  May 17, 2024
FDA Publish Date:  May 18, 2024
Product Type:  Animal & Veterinary  Food & Beverages
Reason for Announcement:  Potential Presence of Loose Metal Pieces
Company Name:  Mars Petcare US, Inc.
Brand Name:  Pedigree
Product Description:  Adult Complete Nutrition Grilled Steak & Vegetable Flavor Dry Dog Food

Macaroni Salad Recalled After Labeling Error Results in Undeclared Wheat Allergen

Reser’s Fine Foods is voluntarily recalling a single item with a specific use by date, produced at a regional facility and distributed to ALDI. The product is the Aldi Deli Macaroni Salad 32 oz, with a Use By Date of Jun/03/24 due to an incorrect label. The incorrect label does not include an allergen callout for wheat.

So in this case, the bottom ingredient label stated coleslaw, which did not match the macaroni product in the container of the top label.  What controls would you put in place to prevent this very simple error?

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/resers-fine-foods-announces-voluntary-recall-single-batch-aldi-macaroni-32-oz-salad-use-date-jun0324
Reser’s Fine Foods Announces Voluntary Recall of Single Batch of Aldi Macaroni 32 oz Salad with Use By Date of Jun/03/24 Due to Unlabeled Wheat Allergen
Summary
Company Announcement Date:  May 17, 2024
FDA Publish Date:  May 17, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Due to Unlabeled Wheat Allergen
Company Name:  Reser’s Fine Foods
Brand Name:  Aldi
Product Description:  Macaroni Salad

Hawaii Firm Recalls Noodle Cups After Missing Egg Contributed by an Ingredient

Sun Noodle, of Honolulu, HI, is recalling approximately 37,158 cases of S&S CUP SAIMIN manufactured from May 9, 2023 – May 8, 2024, because the product may contain undeclared egg white powder.  This frozen product is sold in ready-to-heat cups as noodles with a separate fish cake that contains the allergen in question.  During Sun Noodle’s routine quality checks, the validation of supplier ingredients showed the use of egg white powder not disclosed on the labeling of the final assembled product.  

As part of the Allergen Control, it is critical to evaluate supplied ingredients for allergens and then ensure the design of the label includes those allergens.  In this case, it sounds as though the company did not design the cup labels with clear knowledge of what was in the purchased ingredients.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sun-noodle-issues-allergy-alert-undeclared-egg-ss-frozen-cup-saimin
Sun Noodle Issues Allergy Alert on Undeclared Egg in S&S Frozen Cup Saimin
Summary
Company Announcement Date:  May 16, 2024
FDA Publish Date:  May 17, 2024
Product Type:  Food & Beverages
Reason for Announcement:  May contain undeclared egg white powder
Company Name:  Sun Noodle
Brand Name:  S&S Cup
Product Description:   Saimin Noodles with Soup & Garnishes

Additional Recall Associated with White Confectionary with Potential Salmonella

United Supermarkets is advising guests about a recall by its supplier Palmer Candy of its white coated confectionary items due to possible Salmonella contamination. 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. 

The Palmer recall was published on May 6, 2024.  So here is a delay of 10 days from that until this recall.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/united-supermarkets-advises-guests-new-mexico-and-texas-palmer-candys-voluntary-recall-white-coated
United Supermarkets Advises Guests in New Mexico and Texas of Palmer Candy’s Voluntary Recall of White Coated Confectionary Items Due to Possible Salmonella Contamination
Summary
Company Announcement Date:  May 17, 2024
FDA Publish Date:  May 17, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Possible Salmonella contamination.
Company Name:  United Supermarkets
Brand Name:  United Supermarkets
Product Description:  Chocolate Caramel Corn and Candy Tray

Imported Organic Chia Seeds Recalled Due to Potential Salmonella

Natural Sourcing International is recalling of one lot of imported Great Value Organic Black Chia Seeds 32 oz. due to the potential presence of Salmonella that may be in some of the finished products. The product was imported from Uganda.

There are no reported illness and from the statement, it would seem to follow that the recall was due to testing.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/voluntary-recall-select-great-value-organic-black-chia-seeds-due-possible-presence-salmonella
Voluntary Recall of Select Great Value Organic Black Chia Seeds Due to The Possible Presence of Salmonella
Summary
Company Announcement Date:  May 10, 2024
FDA Publish Date:  May 13, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Potential Presence of Salmonella
Company Name:  Natural Sourcing International
Brand Name:  Great Value
Product Description:  Organic Chia Seeds

NIH Study - CWD Prions From Infected Deer Not Likely Transmitted to Humans

Chronic Wasting Disease (CWD) in deer has been a huge concern for those who consume venison.  A recently released study found that the prions associated with CWD in deer did not transfer to humans in laboratory studies.

"In the new CWD study, the bulk of which was done in 2022 and 2023, the research team validated the study model by successfully infecting human cerebral organoids with human CJD prions (positive control). Then, using the same laboratory conditions, they directly exposed healthy human cerebral organoids for seven days with high concentrations of CWD prions from white-tailed deer, mule deer, elk, and normal brain matter (negative control). The researchers then observed the organoids for up to six months, and none became infected with CWD."

"This indicates that even following direct exposure of human central nervous system tissues to CWD prions there is a substantial resistance or barrier to the propagation of infection, according to researchers. The authors acknowledge the limitations of their research, including the possibility that a small number of people may have genetic susceptibility that was not accounted for, and that emergence of new strains with a lesser barrier to infection remains possible. They are optimistic that the inference of these current data is that humans are extremely unlikely to contract a prion disease because of inadvertently eating CWD-infected cervid meat."

"Prion diseases are degenerative diseases found in some mammals. These diseases primarily involve deterioration of the brain but also can affect the eyes and other organs. Disease and death occur when abnormal proteins fold, clump together, recruit other prion proteins to do the same, and eventually destroy the central nervous system. Currently, there are no preventive or therapeutic treatments for prion diseases."

https://www.nih.gov/news-events/news-releases/nih-study-shows-chronic-wasting-disease-unlikely-move-animals-people
NIH study shows chronic wasting disease unlikely to move from animals to people
Study of cerebral organoids reinforces evidence for substantial species barrier

Friday, May 17, 2024

Beethoven's Deafness May Be Result of Lead Poisoning

A study provided insight on how Beethoven may have lost his hearing and suffered other ailments.  A study found high levels of lead as well as high levels of arsenic and mercury through analysis of his hair and this could have accounted for his health conditions.  "For example, one lock contained 380 micrograms of lead per gram of hair, while the second had 258 micrograms per gram of hair. (Normal levels today would be closer to 4 micrograms or less.) His hair also contained 13 times the normal level of arsenic and four times the typical level of mercury."  He also suffered from Hepatitis B which didn't help.

"One theory involves his penchant for wine; he often consumed an entire bottle in a single day. It wasn't uncommon during that time for wine producers to include lead acetate in their concoctions as a preservative and sweetener. Back then, glass bottles also contained traces of lead. The "Fifth Symphony" composer also ate a lot of fish caught in the Danube, which was known for containing arsenic and mercury, CNN reported."

So to what degree did his tortured condition lead him to writing his highly regarded music?

https://www.livescience.com/archaeology/heavy-metals-in-beethovens-hair-may-explain-his-deafness-study-finds
Heavy metals in Beethoven's hair may explain his deafness, study finds
News
By Jennifer Nalewicki 

May 14, 2024