FDA Issues Health Alert Regarding Infant Formula Linked to Cronobacter and Salmonella Illnesses, Michigan Facility Issues Recall

FDA issued a health warning for infant formula made at Abbott's Michigan facility after that product was linked to complaints of four infant illnesses from three states. "The FDA, along with CDC and state and local partners are investigating four consumer complaints of infant illness related to products from Abbott Nutrition’s Sturgis, MI facility received from 9/20/2021 to 1/11/2022. All of the cases are reported to have consumed powdered infant formula (IF) produced from Abbott Nutrition’s Sturgis, MI facility. These complaints include three reports of Cronobacter sakazakii infections and one report of Salmonella Newport infection in infants. All four cases related to these complaints were hospitalized and Cronobacter may have contributed to a death in one case."

From the CDC..."Cronobacter multi-species complex (formerly Enterobacter sakazakii) is a group of gram-negative bacteria that exists in the environment and which can survive in very dry conditions. The natural habitat for Cronobacter is not known. It has been found in a variety of dry foods, including powdered infant formula, skimmed milk powder, herbal teas, and starches. It has also been found in wastewater. Cronobacter illnesses are rare [2 to 4 cases per year], but they are frequently lethal for infants and can be serious among people with immunocompromising conditions and the elderly."

Cronobacter can cause diarrhea and urinary tract infections in people of all ages, but infection can be very serious in infants (<12 months), especially during the first few weeks after birth. Although cases are rare, the organism can cause a dangerous blood infection (sepsis) or make the linings surrounding the brain and spinal cord swell (meningitis).

"Cronobacter infections have been associated with consumption of reconstituted powdered infant formula. In several outbreak investigations, Cronobacter has been found in powdered infant formula that had been contaminated in the factory. In other cases, Cronobacter might have contaminated the powdered infant formula after it was opened at home or elsewhere. Powdered infant formula is not sterile. Manufacturers report that, using current methods, it is not possible to produce sterile powdered infant formula. At the factory, Cronobacter could get into formula powder if contaminated raw materials are used to make the formula, or if the formula powder touches a contaminated surface in the manufacturing environment."

https://www.fda.gov/food/outbreaks-foodborne-illness/fda-investigation-cronobacter-and-salmonella-complaints-powdered-infant-formula-february-2022
FDA Investigation of Cronobacter and Salmonella Complaints: Powdered Infant Formula (February 2022)
Do not use recalled Similac, Alimentum, or EleCare powdered infant formula
02/18/2022

Arizona Company Recalls Yogurt Raisons After Packaging Equipment Potentially Contaminated with Peanut Allergen

Lehi Valley Trading Company of Mesa, Arizona is issuing a nationwide recall of 8,10 and 12.3 oz packages of Yogurt Raisins, because it may contain undeclared Peanut Allergen.  The recall was initiated after it was discovered that equipment used to package this product may have come in contact with product containing Peanut Allergens.

One may guess that this is a situation where the packaging had run peanut-containing product and then without proper cleaning, packaged the non-peanut yogurt raison product.   Clearly an Allegan Preventive Control was not properly implemented at this step. 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lehi-valley-trading-company-issues-allergy-alert-undeclared-peanut-allergen-yogurt-raisins
Lehi Valley Trading Company Issues Allergy Alert on Undeclared Peanut Allergen in Yogurt Raisins
Summary
Company Announcement Date:  February 17, 2022
FDA Publish Date:  February 17, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared peanuts
Company Name:  Lehi Valley Trading Company
Brand Name:  Snack Worthy, Woody’s Smokehouse, Texas Best Smokehouse
Product Description:  Yogurt Raisins

Canned Chili Recalled When Customer Discovers Product in Can is Cream of Chicken Soup

Morgan Foods, an Austin, Ind., establishment, is recalling approximately 2,205 pounds of Skyline chili due to misbranding and undeclared allergens, the product contains milk, wheat, and soy (allergens) and are not declared on the product label.  The problem was discovered by consumers who reported to the company that the cans labeled as chili contained cream of chicken soup.

https://www.fsis.usda.gov/recalls-alerts/morgan-foods-recalls-skyline-chili-products-due-misbranding-and-undeclared-allergens
Morgan Foods Recalls Skyline Chili Products due to Misbranding and Undeclared Allergens

FDA Warning Letter Issued to Kansas Bakery for Significant GMP Issues

FDA issued a Warning Letter to a Kansas Bakery after an extended inspection in August of 2021.  The company had not issued a response to the observations that were noted on the  Inspection Form 483.

There are a number of issues cited under each of these items.
Item 1 - Lots of bugs including cockroaches and flies.
Item 2 - Really dirty equipment

Item 3 - Poor employee practices when working with RTE foods

Looking at the facility on Google Street View, it is hard to believe that FDA was able to find this shack-like building.

FDA Warning Letter

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bakery-project-inc-dba-delano-bakery-617718-01042022
Bakery Project Inc. dba Delano Bakery
MARCS-CMS 617718 — JANUARY 04, 2022

CT Ice Cream Company Expands Listeria Related Recall To Include all Products

The Royal Ice Cream Company, Inc. of Manchester, CT is expanding its recall of February 6 to include all products manufactured at the facility within the expiration date (as we guessed).   According to the release, "The recall was initiated by Royal Ice Cream after FDA sampling revealed the presence of Listeria monocytogenes on processing equipment. The company is holding future product and testing before releasing distribution of the products as FDA and the company continue their investigation as to what caused the problem."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/royal-ice-cream-company-inc-expands-recall-all-products-within-expiry-because-possible-health-risk
The Royal Ice Cream Company, Inc. Expands Recall All Products Within Expiry Because of Possible Health Risk
Summary
Company Announcement Date:  February 11, 2022
FDA Publish Date:  February 12, 2022
Product Type:  Food & Beverages
Ice Cream/Frozen Dairy  Foodborne Illness
Reason for Announcement:  Listeria monocytogenes
Company Name:  The Royal Ice Cream Company, Inc.
Brand Name:  Royal Ice Cream, Batch, Ronny Brook, and Others
Product Description:  Ice Cream Products

More Enoki Mushrooms Recalled After Sampling Finds Listeria Risk

Two companies are conducting recalls of enoki mushroom due to the potential for Listeria contamination.  

• CONCORD FARMS of Vernon, CA is recalling its 5.25oz (150g) enoki mushrooms, Lot #045633 grown in Korea, after sampling by California Dept of Health (CDPH)
• Jan Fruits Inc. of VERNON, CA is recalling all its cases of its 200g/7.05oz packages of ENOKI MUSHROOM (Product of Taiwan) because it has the potential to be contaminated with Listeria monocytogenes.  The potential for contamination was discovered after a retail sample collected and analyzed by California Department of Public Health (CDPH) and revealed the presence of Listeria monocytogenes in 7.05 oz. package of Enoki mushroom.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/concord-farms-recalls-enoki-mushrooms-due-possible-health-risk-0
Concord Farms Recalls Enoki Mushrooms Due to Possible Health Risk
Summary
Company Announcement Date:  February 09, 2022
FDA Publish Date:  February 10, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Listeria monocytogenes
Company Name:  Concord Farms
Brand Name: Concord Farms
Product Description:  Enoki Mushrooms 

Additional Companies Recall Dried Plums for Lead Levels in Violation of California's Prop 65

Additional companies issued recalls of dried plums for potential to be contaminated from lead.  In the notices, we can see that companies are issuing recalls after testing by the CA State Laboratory found samples were in violation concerning the Prop 65.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/american-gourmet-recalls-saladitos-dry-salted-plums-because-possible-health-risk
American Gourmet Recalls Saladitos Dry Salted Plums Because of Possible Health Risk
Summary
Company Announcement Date:  February 10, 2022
FDA Publish Date:  February 10, 2022
Product Type:  Food & Beverages  Snack Food Item
Reason for Announcement:  Potential to be contaminated with lead
Company Name:  American Gourmet
Brand Name:  American Gourmet
Product Description:  Saladito (Dried Salted Plums)

Europe - Ongoing Salmonella Outbreak Associated with Eggs Affects Close to 300

The European Center of Disease Prevention and Control (ECDC) provided a report of an ongoing Salmonella outbreak of 272 cases and 2 deaths (Denmark (n=3), France (n=216), the Netherlands (n=12), Norway (n=7), Spain (n=22), and the UK (n=12)). The organism was linked to an earlier outbreak in 2019 which point to a Spanish farm, although the data suggests a wider distribution where "there may be multiple heterogeneous sources of S. Enteritidis ST11, and the outbreak strain could also be circulating at other farms, inside or outside Spain."

European Centre for Disease Prevention and Control
https://www.ecdc.europa.eu/en/publications-data/multi-country-outbreak-salmonella-enteritidis-sequence-type-st11-infections
Multi-country outbreak of Salmonella Enteritidis sequence type (ST)11 infections linked to eggs and egg products

Three Food Importers Issued Warning Letters for Not Having Required FSVP for Imported Food Products

FDA issued Warning Letters to three food importers for not having FSVP for the items they import.

• Molino Enterprises One, Inc., located at 392 E 197th Street, Bronx, NY did not develop, maintain, and follow an FSVP for imported whole wheat breadsticks.
• Ding Tea Balboa located at 5945 Balboa Ave., San Diego, CA 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, did not develop an FSVP for any of the foods imported.
• VHRK Food Inc., located at 810 Bonnie Lane, Elk Grove Village, IL.did not develop an FSVP for any of the foods imported, including the following  Dry dates powder, Brown Chori (peas), Black pepper, and Sun dried gooseberries

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/molino-enterprises-one-inc-619323-01072022
Molino Enterprises One, Inc.
MARCS-CMS 619323 — JANUARY 07, 2022