FDA Warning Letter Highlights Importance of Assuring Foreign Material Control for Imported Food

FDA issued a Warning Letter to Yichang Jiayuan Foodstuffs Co., Ltd of Hubei, China, a packer of ready-to-eat (RTE) Mandarin Oranges in light syrup in glass jars.  The inspection found that in the company's "hazard analysis for mandarin orange in syrup products identified the physical hazard of glass chips, but [then] determined that this hazard does not require a preventive control."

The FDA report stated "Glass fragments can be introduced into food whenever processing involves the use of glass containers. Normal handling and packaging methods, especially mechanized methods, can result in breakage. Ingesting glass fragments can cause injury to the consumer. In particular, your (b)(4). You did not investigate the root cause or evaluate other potentially affected products as a result of this rejection. The subject lot was shipped to the U.S."

During the inspection, FDA noted, "we noted deficiencies regarding your control of the glass hazard using your (b)(4) machine procedures. Specifically, on September 26, 2022, the first day of the inspection, your (b)(4) machine ((b)(4)) failed to reject a sample container of your RTE Mandarin Orange in light syrup in a glass jar which contained glass fragments for the purpose of demonstrating a challenge test for your (b)(4) machine. Your firm placed glass fragments into two (b)(4) oz. glass jars of mandarin oranges in light syrup to demonstrate the working conditions of your (b)(4) machine. However, your (b)(4) machine failed to reject one of the two jars. Your employees proceeded to alter settings on your firm’s machine until the machine rejected both sample jars of product. Your Corporate Quality Assurance Director also stated that your (b)(4) machine ((b)(4)) had never been calibrated previous to this. This indicates that your (b)(4) machine procedures did not control the hazard of glass contamination."

As part of the Foreign Supplier Verification Program, the FSVP importer must conduct a hazard analysis as well, and as part of this, would also need to recognize glass as a potential hazard to be controlled by the supplier.  With that recognition as a hazard requiring control, the FSVP importer would need to establish verification activities to ensure the supplier was indeed controlling the hazard.

FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/yichang-jiayuan-foodstuffs-co-ltd-655593-05052023

Yichang Jiayuan Foodstuffs Co., Ltd
MARCS-CMS 655593 — MAY 05, 2023

Ohio Establishment Recalling RTE Chili Topping Due to Undeclared Soy

J.T.M. Provisions Company, a Harrison, Ohio establishment, is recalling approximately 200 pounds of ready-to-eat (RTE) chili topping product due to misbranding and an undeclared allergen - the product labeled as chili topping may actually contain beef taco filling, which contains soy, a known allergen, that is not declared on the product label.  The problem was discovered when the producing establishment notified FSIS that it had received a consumer complaint that bags labeled as homestyle chili topping contained beef taco filling.

https://www.fsis.usda.gov/recalls-alerts/j-t-m--provisions-company-recalls-ready-eat-homestyle-chili-topping-product-due
J.T.M. Provisions Company Recalls Ready-To-Eat Homestyle Chili Topping Product Due to Misbranding and an Undeclared Allergen
J.T.M. PROVISIONS COMPANY

FSIS Announcement

WASHINGTON, June 9, 2023 – J.T.M. Provisions Company, a Harrison, Ohio establishment, is recalling approximately 200 pounds of ready-to-eat (RTE) chili topping product due to misbranding and an undeclared allergen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product labeled as chili topping may actually contain beef taco filling, which contains soy, a known allergen, that is not declared on the product label.

Ohio Establishment Recalls RTE Beef Chili for Extraneous Material - White Plastic

J.T.M. Provisions Company, a Harrison, Ohio establishment, is recalling approximately 22,530 pounds of frozen, ready-to-eat beef chili with beans products that may be contaminated with extraneous materials, specifically white plastic.  The problem was discovered after the company received a customer complaint about semi-rigid white plastic material found in the frozen, ready-to-eat beef chili with beans and notified FSIS.

https://www.fsis.usda.gov/recalls-alerts/j-t-m--provisions-company-recalls-frozen-ready-eat-beef-chili-products-due-possible
J.T.M. Provisions Company Recalls Frozen Ready-To-Eat Beef Chili Products Due To Possible Foreign Matter Contamination
J T M PROVISIONS COMPANY
FSIS Announcement

WASHINGTON, June 4, 2023 – J.T.M. Provisions Company, a Harrison, Ohio establishment, is recalling approximately 22,530 pounds of frozen, ready-to-eat beef chili with beans products that may be contaminated with extraneous materials, specifically white plastic, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Imported Pork Rinds Recalled After Discovery of Guatemalan Origin, A USDA Non-eligible Country

DEKA Trading Corp., the importer of record located in Miami, Fla., is recalling approximately 13,771 pounds of imported ready-to-eat pork rind products. The products were imported from Guatemala, a country ineligible to export meat products to the United States.  The problem was discovered during routine FSIS surveillance activities. Guatemala is not eligible to import meat products into the United States.

https://www.fsis.usda.gov/recalls-alerts/deka-trading-corp--recalls-ineligible-ready-eat-pork-rind-products-imported
DEKA Trading Corp. Recalls Ineligible Ready-To-Eat Pork Rind Products Imported from Guatemala

FSIS Announcement

WASHINGTON, June 2, 2023 – DEKA Trading Corp., the importer of record located in Miami, Fla., is recalling approximately 13,771 pounds of imported ready-to-eat pork rind products. The products were imported from Guatemala, a country ineligible to export meat products to the United States, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

MA Cheese Company Expands Recall to Additional Product That Was Underprocessed

Cricket Creek Farm of Williamstown, MA is expanding their May 30th recall of Sophelise and Tobasi cheeses due to potential contamination with Listeria monocytogenes to include one lot of Berkshire Bloom cheese because pasteurization records did not illustrate the heating element reached required temperature.

From the announcement...."One hospitalization due to Listeria monocytogenes has been reported to date associated with the Sophelise cheese. Following this customer notification of illness, products purchased by this individual were tested by Biotrax Testing Laboratory and the current batch of Sophelise cheese was determined to be positive for Listeria monocytogenes. These three batches of Tobasi cheese were also determined to be positive for Listeria monocytogenes . The production record for the Berkshire Bloom cheese did not illustrate fully compliant temperatures for the heating element."

It seems to me with the level of Listeria positive samples, all cheese products should be recalled.  While this recall was expanded to a lot that may have not received adequate process, there would be a post-process environmental contamination issue that would affect all cheese processed.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cricket-creek-farm-expands-recall-cheeses-because-potential-listeria-monocytogenes-contamination-and
Cricket Creek Farm Expands Recall of Cheeses Because of Potential Listeria monocytogenes Contamination and Inadequate Pasteurization
Summary
Company Announcement Date:  June 12, 2023
FDA Publish Date:  June 12, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Potential contamination with Listeria monocytogenes.
Company Name:  Cricket Creek Farm, LLC
Brand Name:  Cricket Creek Farm
Product Description:  Sophelise, Tobasi, and Berkshire Bloom Cheeses

Additional Frozen Strawberries Recalled Due to Potential for Hepatitis A Contamination

Wawona Frozen Foods is voluntarily recalling year-old packages of its Organic DayBreak Blend distributed to Costco Wholesale stores in Arizona, California, Colorado, Utah and Washington from April 15, 2022 to June 26, 2022 because the DayBreak Blend includes organic frozen strawberries grown in Mexico which may have the potential to be contaminated with Hepatitis A.  While the Organic DayBreak Blend was distributed to Costco stores last year, they have “Use By” dates of 09/23/2023, 09/29/2023, 09/30/2023 and 10/18/2023 therefore consumers are urged to check their freezers

Willamette Valley Fruit Co. is recalling product distributed through Walmart under the Great Value label including Sliced Strawberries, Mixed Fruit and Antioxidant Blend, Costco and HEB under the Rader Farms Organic Fresh Start Smoothie Blend, and Rader Farms Organic Berry Trio Because of Possible Health Risk

These is linked to same supplier as the California Splendor recall back in March of 2023. and are part of an FDA Investigation.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wawona-frozen-foods-voluntarily-recalls-organic-daybreak-blend-processed-and-sold-2022-due-possible
Wawona Frozen Foods Voluntarily Recalls Organic Daybreak Blend Processed and Sold in 2022 Due to Possible Health Risk
Summary
Company Announcement Date:  June 08, 2023
FDA Publish Date:  June 09, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Potential to be contaminated with Hepatitis A
Company Name:  Wawona Frozen Foods, Inc.
Brand Name:  Wawona Frozen Foods
Product Description:  Organic Daybreak Blend 4lb bags of frozen fruit

IL Company Recalls Chocolate Covered Raisons After Chocolate Covered Peanuts Found in Package

Regal Health Food International, Inc. of Chicago, Illinois is recalling Regal Gourmet Snacks Milk Chocolate Raisins 16 oz tub because it may contain undeclared peanuts.  The product was recalled after "milk chocolate peanuts were discovered in a tub labeled for milk chocolate raisins. The presence of the peanuts in the raisins package was caused by an error in processing procedure which has since been corrected."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/regal-health-food-international-issues-allergy-alert-undeclared-peanut-milk-chocolate-covered
Regal Health Food International Issues Allergy Alert on Undeclared Peanut in Milk Chocolate Covered Raisins
Summary
Company Announcement Date:  June 07, 2023
FDA Publish Date:  June 08, 2023
Product Type:  Food & Beverages  Snack Food Item 
Reason for Announcement:  Undeclared peanuts.
Company Name:  Regal Health Food International, Inc.
Brand Name:  Regal Gourmet Snacks
Product Description:  Milk Chocolate Raisins

Imported Lamb Meat from Chile Recalled After Failing to Get USDA Reinspection

E.N.A. Meat Packing Inc, the importer of record located in Paterson, N.J., is recalling approximately 39,947 pounds of frozen, raw lamb products that were imported without the benefit of import reinspection.  The problem was discovered during routine FSIS monitoring when a shipment of frozen, raw lamb carcasses and bone in lamb leg products imported from Chile was identified that was not presented for FSIS import reinspection.

https://www.fsis.usda.gov/recalls-alerts/e-n-a--meat-packing-inc--recalls-frozen-raw-lamb-products-imported-without-benefit
E.N.A. Meat Packing Inc. Recalls Frozen, Raw Lamb Products Imported Without Benefit of Import Reinspection

FSIS Announcement

WASHINGTON, June 1, 2023 – E.N.A. Meat Packing Inc, the importer of record located in Paterson, N.J., is recalling approximately 39,947 pounds of frozen, raw lamb products that were imported without the benefit of import reinspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

NJ Health Officials Investigating a Hepatitis E Outbreak Potentially Linked to Food

New Jersey Environmental Health officials are investigating an outbreak of Hepatitis E.  According to the report, one potential source may be undercooked pork.

Hepatitis E, an emerging threat in the industrialized world, has been more an issue in the developing world where it causes large outbreaks and presents a significant public-health problem. It is a non-enveloped virus (although it can be enveloped when found in the bloodstream).  "In endemic regions where most infections are waterborne the primary prevention strategy involves improving sanitation and drinking water facilities. It has been shown that failure to take action to sterilize drinking water during epidemics is associated with larger scale outbreaks. In areas where zoonotic transmission is predominant infection can be prevented by ensuring proper preparation of food products. Meat products, particularly pork and game, should be cooked thoroughly."

https://www.itv.com/news/channel/2023-05-28/environmental-health-investigating-after-hepatitis-e-cases-found
Environmental Health investigating small number of Hepatitis E cases in Jersey
Sunday 28 May 2023 at 3:17pm

Environmental Health says it is investigating a small number of Hepatitis E cases in Jersey.