Powdered Infant Formula Recalled for Potential Cronobacter Found by Lab Outside of US

Reckitt/Mead Johnson Nutrition (MJN), a producer of nutrition products, announced today that it has voluntarily chosen to recall from the U.S. market select batches of Nutramigen Powder, a specialty infant formula for the dietary management of Cows Milk Allergy (CMA) in 12.6 and 19.8 oz cans, due to a possibility of contamination with Cronobacter sakazakii in product sampled outside the U.S. All product in question went through extensive testing by MJN and tested negative for the bacteria.

Nutramigen in 12.6 and 19.8 oz containers was manufactured in June 2023 and distributed primarily in June, July, and August 2023. Based on the limited availability of the remaining stock of this special infant formula, it is believed that much, if not all, of the products recalled in the United States have been consumed. There are no reports of illnesses or adverse events to date.

These types of cases come up time to time where sampling and testing occurs outside of US.  Questions arise including whether this non-domestic laboratory has the necessary credentials as well as sampling and testing capabilities.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/reckittmead-johnson-nutrition-voluntarily-recalls-select-batches-nutramigen-hypoallergenic-infant
Reckitt/Mead Johnson Nutrition Voluntarily Recalls Select Batches of Nutramigen Hypoallergenic Infant Formula Powder Because of Possible Health Risk
Summary
Company Announcement Date:  December 30, 2023
FDA Publish Date:  December 31, 2023
Product Type:  Food & Beverages  Infant Formula & Foods
Reason for Announcement:  Potential Cronobacter sakazakii contamination
Company Name:  Reckitt/Mead Johnson Nutrition
Brand Name:  Enfamil
Product Description:  Nutramigen Powder infant formula in 12.6 and 19.8oz cans

MD Firm Recalls Soybean Sprouts After State Lab Sampling Finds Listeria

Nam & Son of MD, Jessup, MD is recalling one-pound bags of soybean sprouts, with the sell-by date of December 14, 2023, because it has the potential to be contaminated with Listeria monocytogenes.  The product has been distributed to retail stores in VA ranging from December 6 -7, 2023.  The recall was initiated after a random sample was collected and analyzed by the state of Virginia, which resulted in confirmation of presence Listeria Monocytogenes in the product. The company has actively started investigating the root cause of the problem.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nam-son-md-recalls-soybean-sprouts-because-possible-health-risk
Nam & Son of MD Recalls Soybean Sprouts Because of Possible Health Risk
Summary
Company Announcement Date:  December 28, 2023
FDA Publish Date:  December 28, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Potential contamination of Listeria monocytogenes
Company Name:  Nam & Son of MD
Brand Name:  Sam Sung
Product Description:  Soybean Sprouts in 1 lb bags

Illinois Establishment Recalls Ground Beef After Testing Finds E. coli O157:H7

Valley Meats, LLC, a Coal Valley, Ill. establishment, is recalling approximately 6,768 pounds of raw ground beef products that may be contaminated with E. coli O157:H7.  The raw ground beef items were produced on December 22, 2023.  The problem was discovered when the establishment notified FSIS that samples of ground beef products submitted to a third-party laboratory for microbiological analysis tested positive for E. coli O157:H7. There have been no confirmed reports of adverse reactions due to consumption of these products.


https://www.fsis.usda.gov/recalls-alerts/valley-meats-llc-recalls-ground-beef-products-due-possible-e--coli-o157h7
Valley Meats, LLC, Recalls Ground Beef Products Due to Possible E. Coli O157:H7 Contamination
FSIS Announcement

WASHINGTON, Dec. 31, 2023 – Valley Meats, LLC, a Coal Valley, Ill. establishment, is recalling approximately 6,768 pounds of raw ground beef products that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

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

TX Food Warehouse Issued Warning Letter for Excessive Rodent Activity

FDA issued a Warning Letter to US Gulf Coast Trading Co, a refrigerated, frozen, and ambient food product warehouse located at in Houston, TX.  The primary issue was the lack of pest control, specifically for rodents.

Pest Control

• The biggest concern is the evidence of excessive rodent activity "including rodent excreta pellets (REPs) in numbers too numerous to count (TNTC), gnaw marks in food and food packaging, nesting material, live maggots, and other apparent excrement throughout your facility, including areas where human food is routinely stored"

Facility Maintenance

• Gaps were observed along the bottom, (b)(4), and top of the (b)(4) bay door when the door was fully closed. The roll-up door opens directly to the exterior (b)(4) of the warehouse, which could allow for the entrance of pests into the facility. Food products such as packaged tortillas, (b)(4), herbal tea, and stuffed eggplant were stored directly approximately 3 feet to this bay door.

Cleaning

• Did not clean non-food contact surface in a manner and as frequently as necessary to protect against allergen cross-contact and against contamination,

Improper Storage

• Did not store food under conditions that protect against contamination of food, as required by 21 CFR § 117.93. Specifically, on August 7-10 and 15, 2023, the (b)(4) bay door, (b)(4) bay door, and entry door into the warehouse in the (b)(4) of the (b)(4) wall remained open when not in use and for extended periods. These conditions could allow for the entrance of pests into the facility, which may cause contamination of food products stored inside the warehouse.

Grounds

• On August 7-10 and 15, 2023, numerous empty pallets being stored directly against the exterior corner of the (b)(4) wall, directly adjacent to the (b)(4) bay door, which remained open when not in use and for extended periods of time during the inspection.
• On August 7-10 and 15, 2023, the grass and weeds located at the back and east side of the facility were observed to be overgrown that may lead to the harborage of pests.

Chemical Storage

• Did not store a toxic chemical in a manner that protects against contamination, as required by 21 CFR § 117.35(b)(2). Specifically, on August 7-10, 2023, a container of insect killer was observed being stored directly adjacent to a pallet containing boxes of jarred jam and canned olives at the end of row (b)(4) of the warehouse and 20 lb. sacks of steamed basmati rice approximately 8 ft. away along the (b)(4) wall of the warehouse.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/us-gulf-coast-trading-co-inc-668767-12052023
WARNING LETTER

US Gulf Coast Trading Co., Inc.
MARCS-CMS 668767 — DECEMBER 05, 2023

Warning Letter Issued to KY Bakery Detail Lack of GMPs

In a Warning Letter issued by FDA to a small KY desert company, Deserts by Hellen, FDA identified numerous GMP issues that demonstrate a lack of proper sanitary controls.    This is often an issue for  small retail operations that grow to where they want to distribute product - it exposes this lack of understanding of what is expected from a GMP perspective.

Handwashing / glove usage

• Two employees wearing gloves retrieved RTE chocolate cakes from the walk-in freezer. They touched the door handles, the interior surface of the walk-in freezer door, and plastic strip curtains that had a build-up of visible residue. The employees then touched the RTE chocolate cakes without washing and sanitizing their hands and changing their gloves. The employee then scooped chocolate sprinkles by hand, wearing the same gloves, and coated the cake with chocolate sprinkles.
• During the manufacturing of RTE Mile High Chocolate Cake, an employee moved a trash can using their gloved hands, and then continued to apply chocolate sprinkles to the RTE cake without first washing and sanitizing their hands and changing their gloves.

Facilities (buildings, fixtures, and other physical facilities) 

• A metal storage shelf in the walk-in cooler was visibly unclean with a green and white substance, mold-like in appearance.
• Apparent food residue and apparent green and white mold-like substance on a (b)(4) plastic pallet located in the walk-in cooler. The (b)(4) plastic pallet held a (b)(4) bucket of “(b)(4) WHOLE CHERRY FILLING.”
• Standing brown liquid in the drainage basin located in the packaging room. The drainage basin also contained apparent dirt, concrete pieces, and pieces of cloth.
• Pitted floors throughout the facility; they were visibly unclean and missing sealant in multiple areas. This is a repeat observation from FDA’s April 2022 inspection.
• Unclean interior surfaces of the dishwashing machine with apparent mineral and food residue buildup. This is a repeat observation from FDA’s April 2022 inspection. Additionally, the water in the tank of the dishwashing machine was observed to contain food residue, that water is circulated and sprayed over the dishes as part of the wash/rinse process.

Sanitation

• Employees used a metal scoop and spatula stored in the drawers of a (b)(4) toolbox that were visibly unclean with apparent food residue to apply icing to RTE Mile High Chocolate Cake without cleaning and sanitizing the utensils prior to use.
• A buildup of food residue was observed on the interior sides and slicing blade of the cake slicer used to slice RTE Jalapeno Cornbread in the packaging room.
• A buildup of food residue on the underside, spindle and rear splash guard of the stand mixers being used to manufacture RTE chocolate buttercream icing and Jalapeno Cornbread batter.
• Food residue on the base, underside, locking lever and wheels of the batter dispensing machine located in the production room that was being used to manufacture RTE Jalapeno Cornbread batter.
• Build-up of food residue on the top shelf extending over the stove, the stove’s backsplash, and the exhaust hood above the stove. An employee used the stove to melt margarine in a metal pot. This is a repeat observation from FDA’s April 2022 inspection.
• Visibly unclean exteriors of various stand mixer bowls stored on metal shelving. An employee retrieved one such bowl and used it to manufacture Jalapeno Cornbread batter without cleaning and sanitizing the bowl prior to use.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/desserts-helen-inc-659181-09112023
Desserts by Helen, Inc.

MARCS-CMS 659181 — SEPTEMBER 11, 2023

Warning Letter to Cheese Operation Highlights Insufficient Cleaning and Listeria Contamination

FDA issued a Warning Letter to a NY Cheese processor.  In brief, they were found to have an ongoing Listeria issue as identified in 2023 recall situation for Listeria as well as an recall in 2017.  During a June 2023 inspection of the facility, FDA found Listeria in the facility as well as identified many GMP issues related to cleaning and poor equipment.  The identified cleaning issues are those types of things that can be easy to perhaps overlook, or more likely, just accept as normal after seeing it over a long period of time.  (This is where an outside audit can help - providing a different set of eyes to see those things we have become accustomed to).

Positive LM Findings

• FDA laboratory analysis of environmental samples collected at the facility on June 21, 2023 confirmed that four (4) of fifty (50) environmental swabs were positive for LM and those collected on June 26, 2023 confirmed that four (4) of fifty six (56) environmental swabs were positive for LM. Of the positive findings, one (1) of the L. monocytogenes positive swabs was collected from the food contact surface of a cutting board that was being used to cut RTE Jersey Girl cheese.
• Furthermore, in 2017, New York State Department of Agriculture and Markets (NYSDAM) collected a finished product sample of your firm’s Toma Celena cheese (lot #51017) which tested positive for L. monocytogenes. In response to this finding, your firm tested (b)(4) lots of finished products and found two additional lots (lots #52417 and #60717) to be positive for L. monocytogenes.
• The environmental swabs collected at the facility during FDA’s most recent inspection and finished product samples from 2017 represent four (4) different strains of L. monocytogenes. None of them matched any clinical isolates. 
• Conclusion - "Our findings indicate that your firm is neither achieving satisfactory control against the presence of L. monocytogenes within your facility nor implementing effective methods and controls to eliminate this human pathogen or minimize exposure to food and food-contact surfaces. Once it is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. It is essential to identify the harborage sites in the food processing plant and equipment where this organism is able to grow and survive and to take such corrective actions as are necessary to eradicate the organism."

Cleaning issues - the facility did not clean adequately clean environmental areas including food-contact surfaces

• "Old, white-yellow cheese/wax/salt-like residues from previous lots of cheese were observed on the stainless-steel and plastic tables in your waxing/drying room on June 21 and 26, 2023. These tables were being used to store wheels and blocks of drying cheese products. Thereafter on July 18, 2023, the same residues were observed on these tables.  The company stated they had cleaned and sanitized these tables three times and were unable to remove the residues, but the investigator was able to scrape off the residue from the table."
• "Investigators observed the underside of a stainless-steel table in the manufacturing room had a heavy buildup of black-brown mold-like or rust-like residues on its surface. This table is used to store raw milk cheese products."
• "Areas of black and black-brown mold-like residues on the walls and baseboards in the manufacturing room, where products are processed. Furthermore, environmental sub #62, which was taken from the floor/wall baseboard (containing these residues) in the manufacturing room on June 26, 2023, was found positive for L. monocytogenes."
• "Areas of black and black-brown mold-like substances on the door and around the door handle to the main cheese cave, where products are aged. Furthermore, environmental sub #57, which was collected from this door handle on June 26, 2023, was found positive for L. monocytogenes."
• "Areas of the floor in the manufacturing room, where your products are processed, were pitted, and had uneven and rough surfaces. Furthermore, environmental subs #61 and #91, which were taken from two different floor areas in the manufacturing room on June 26, 2023, were both found positive for L. monocytogenes."
• "The bottom of the door, inside the main cheese cave, where your products are aged, was flaking a tape-like material. Furthermore, environmental sub #2, which was collected from this surface on June 21, 2023, was found positive for L. monocytogenes."
• "Areas of the floor in the brine area in the main cheese cave, where products are aged, were pitted, and had uneven and rough surfaces. Furthermore, environmental sub #9, which was collected from this surface on June 21, 2023, was found positive for L. monocytogenes."
• "Buildup of water on the floor around the (b)(4) near the raw milk receiving room, where you intake the raw cow’s milk that is used to make your products. The company  stated that the (b)(4) has had a “constant leak”, and that this has been an ongoing issue."
•  "Areas of black and black-brown mold-like substances and exposed foam-like insulation on the ceiling in the (b)(4) cheese cave, which is where your products are aged."
• "A fan in the waxing/drying room that was blowing on cheese product was observed to be covered with a thick layer of dust."

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cooperstown-cheese-company-llc-667551-11242023
WARNING LETTER
Cooperstown Cheese Company, LLC
MARCS-CMS 667551 — NOVEMBER 24, 2023

CO Establishment Recalls Ground Beef for E. coli O103 After Positive FSIS Testing

Scanga Meat Company, a Salida, Colorado establishment, is recalling approximately 563 pounds of ground beef products that may be contaminated with E. coli O103.  The raw ground beef products were produced on December 11, 2023.  The problem was discovered during routine FSIS testing and the sampling results showed the presence of E. coli O103. There have been no confirmed reports of illness due to consumption of these products.

https://www.fsis.usda.gov/recalls-alerts/scanga-meat-company-recalls-ground-beef-products-due-possible-e--coli-o103
Scanga Meat Company Recalls Ground Beef Products Due to Possible E. Coli O103 Contamination

WASHINGTON, Dec. 22, 2023 – Scanga Meat Company, a Salida, Colorado establishment, is recalling approximately 563 pounds of ground beef products that may be contaminated with E. coli O103, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Label Design Issue Results in Missing Fish Allergen from Kimchi Label

World Variety Produce, Inc. of Los Angeles, CA is recalling Melissa's Kimchi Hot 14 oz, because of mislabeling of allergen ingredient "Fish" was not listed in the ingredient panel within the allergen information panel.   The recall was as the result of an internal finding of an product artwork review by Melissa's Design/Artwork department which revealed that the printed artwork was mislabeled and did not have an allergen listing of "Fish". World Variety Produce, Inc. has ceased the production and distribution of the product as FDA, World Variety Produce, Inc. continues their investigation as to what caused the issue.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/world-variety-produce-inc-recalls-kimchi-hot-because-possible-health-risk
World Variety Produce, Inc. Recalls Kimchi Hot Because of Possible Health Risk
Summary
Company Announcement Date:  December 26, 2023
FDA Publish Date:  December 26, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Fish
Company Name:  World Varity Produce, Inc.
Brand Name:  World Varity Produce, Inc.
Product Description:  Melissa’s Hot Kimchi