FDA Warning Letters Issued to Three Food Importers for Not Having FSVP for Imported Food Items

FDA issued Warning Letters to three import companies for issues with their FSVP.  The three companies did not have FSVP for the imported food items.

• OCM Group USA Inc. of City of Industry, CA did not develop, maintain, and follow an FSVP for Crushed Chili, imported from (b)(4) and (b)(4) (Sesame), imported from (b)(4).
• FDA conducted a remote Foreign Supplier Verification Program (FSVP) inspection of FSVP records for the firm V-Nine Inc., of Maryland.  The company did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a).imported pad thai sauce.
• Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Aspen Sales Group, of, Bedminster, NJ  as well as an on-site inspection on March 29, 2018.  The company did not develop, maintain or follow a FSVP for fries imported from your foreign supplier, and Refined Sugar imported from your foreign supplier, (b)(4), located in (b)(4)..

FDA Warning Letter - CA Ice Cream Facility Has Inadequate Listeria Control

FDA issued a Warning Letter to a California ice cream company primarily due to inadequate Listeria control.  The FDA "inspection was initiated in response to your firm’s voluntary recall of Peekaboo branded Mint Chocolate Chip with Hidden Spinach Ice Cream (Best Before 10/08/2021), due to findings of Listeria monocytogenes (L. monocytogenes) in the product."

Listeria was found in multiple locations including the bristles of a broom.  The facility also continuously found Listeria during sampling but the corrective actions were not effective.  From the FDA report -  "it appears that your corrective actions were not adequate to address your findings, as evidenced by the recurring findings of Listeria within your environment, including some within the same locations."

This is interesting  - "You identified improper employee handling of boxes of chocolate chips that were transported into the RTE Production Room via dollies and placed on the floor before being added to the (b)(4) machine as the root cause of L. monocytogenes finding in the recalled lot of Peekaboo brand ice cream. Your corrective actions included prohibiting the use of floor dollies on the production floor and replacing them with a (b)(4) cart for transporting and holding inclusions in the RTE Production Room. However, on May 21, 2020, this cart was observed sitting outside the building with one of its wheels in standing ground water. You swabbed this ground surface on May 21, 2020, and the result was positive for Listeria spp. On May 27, 2020, this cart was observed inside the RTE Production Room and you did not have a process for cleaning and sanitizing it when bringing it from the outside into the RTE Production Room."

There were a number of GMP issues including dripping hoses, the bringing in of items from an outside warehouse into an RTE environment, inadequate hand washing station, and improper sanitation of utensils and equipment.

This Week In Mislabeled Products for Week Ending October 30, 2020

Improperly Designed Label Issue - Russ Davis Wholesale of Wadena, Minnesota is recalling individual serving cups of Mixed Veggie Cup with Dip because it may contain undeclared Egg.  The issue was discovered by Quality Control team during a routine label audit, where egg was noted on the dressing ingredient and was not reflected on the finished product label.

More Print and Apply Label Issues - Whole Foods Market is voluntarily recalling select prepared Macaroni & Cheese products from stores across five states because they contain undeclared egg. 

Regular Breaded Halibut Put in Gluten-Free Box - Orca Bay Foods of Seattle, WA is recalling 4,450 lb. (356 cases) of 10 oz. retail box Trader Joe's brand Gluten Free Battered Halibut SKU 00503822, because it contains undeclared wheat and milk allergens.  The recall was initiated after it was discovered that product containing Wheat and Milk was distributed in packaging that did not reveal the presence of the allergens.

CDC Outbreak Notice - Listeria in Unidentified Deli Meat Linked to 10 Cases of Listeria with One Death

The CDC issues a notification of an ongoing outbreak of Listeria that has been linked to Italian style deli meat.  "As of October 22, 2020, a total of 10 people infected with the outbreak strain of Listeria monocytogenes have been reported from three states", Florida, Massachusetts, and New York, with those cases occurring from August thru October.  Deli meat were reported as both pre-packaged and deli-sliced.

CDC Outbreak Notice
https://www.cdc.gov/listeria/outbreaks/delimeat-10-20/index.html
Outbreak of Listeria Infections Linked to Deli Meats
Posted October 23, 2020 at 4:45 PM ET

At A Glance
Reported Cases: 10
States: 3
Hospitalizations: 10
Deaths: 1

Latest Outbreak Information

• 10 people infected with the outbreak strain of Listeria have been reported from Florida, Massachusetts, and New York.
• All 10 ill people were hospitalized. One death has been reported from Florida.
• Epidemiologic evidence shows that deli meat is a likely source of this outbreak.
• In interviews with 9 ill people, all reported eating Italian-style meats, such as salami, mortadella, and prosciutto. They reported purchasing prepackaged deli meats and meats sliced at deli counters at various locations.
• A specific type of deli meat and common supplier have not yet been identified.

China - Nine People Dead After Consuming Noodles Made From Fermented Corn Flour Contaminated with Toxin from Burkholderia gladiol

In China, nine people died after eating noodles made from contaminated corn flour. The flour was found to contain the toxin bongkrekic acid which is produced by bacterium Burkholderia gladioli.

Bongkrekic acid, or BA, is a highly toxic compound that inhibits the enzyme ADP/ATP translocase, the enzyme that exchanges ATP and ADP across the mitochondrial membrane. The toxin is preformed in the food. It is said to be an issue in fermented coconut fiber and corn flour. "Bongkrekic acid production depends on two distinct and sequential environmental conditions: those that support bacterial growth and proliferation, followed by those that favor BA production .Bongkrekic acid is produced in warm environments (22–30 °C) with a neutral pH, the same conditions under which tempe is made. Production is also dependent on the presence of fatty acids, particularly those found in coconut and corn"

A similar foodborne illness outbreak occurred in 2015 in Mozambique when after consuming pombe, a traditional alcoholic beverage product, during a funeral event, 230 became sick and 75 died, In this case, the provider of the pombe used corn flour that had previously gotten wet.

Newsweek
https://www.newsweek.com/family-members-die-homemade-noodles-1541320?amp=1
9 Family Members Die After Eating Year-Old Homemade Noodles

Imported Mini Jelly Cups Recalled Due to the Potential as a Choking Hazard

Two NY importing companies are recalling bags of mini jelly cup products due to the fact the product represents a choking hazard, especially for children.  While there have been no reported cases of choking, the product parameters indicate it can be an issue.

The Consumer Product Safety Commission has established standards for what represents a choking hazard.  https://www.cpsc.gov/Business--Manufacturing/Business-Education/Business-Guidance/Small-Parts-for-Toys-and-Childrens-Products/








https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hadson-toko-trading-co-inc-recalls-eishindo-mini-cup-jelly-50pcs-because-potential-choking-hazard
Hadson Toko Trading Co., Inc. Recalls Eishindo Mini Cup Jelly (50pcs) Because of Potential Choking Hazard
Summary
Company Announcement Date: October 14, 2020
FDA Publish Date:  October 14, 2020
Product Type:  Food & Beverages
Reason for Announcement:  Product poses a choking hazard.
Company Name:  Hadson Toko Trading Co., Inc.
Brand Name:  Eishindo
Product Description:  Jelly Cups

Organic Parsley Product Recalled After Testing Finds Salmonella in Same Lot

Red Monkey Foods, Inc. is recalling select organic parsley and another product made with this parsley after a recall was issued by its supplier, High Quality Organics (HQO). HQO issued a recall for this lot of parsley after another customer tested and found Salmonella in a portion of this same lot. 

The product was shipped nation wide under Cost Plus , Great Value, O Organics and Full Circle.  There have been no reported illnesses.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/red-monkey-foods-inc-recalls-parsley-and-herbes-de-provence-because-possible-health-risk
Red Monkey Foods, Inc. Recalls Parsley and Herbes De Provence Because of Possible Health Risk
Summary
Company Announcement Date:  October 13, 2020
FDA Publish Date:  October 13, 2020
Product Type:  Food & Beverages
Reason for Announcement:  Salmonella
Company Name:  Red Monkey Foods, Inc.
Brand Name:  Cost Plus World Market, Great Value, O Organics, Full Circle
Product Description:  Parsley and Herbes De Provence

Research Study - Prevalence of Listeria in Frozen Produce in England

A study out of the UK looked at the prevalence of Listeria monocytogenes in frozen fruits and vegetables sold at retail. Of the 1050 samples tested, "There were 78 samples (7%) from which L. monocytogenes was detected and 101 (10%) from which other Listeria species were detected. Neither L. monocytogenes nor other Listeria species were detected at levels of >100 cfu/g in any samples."

While these samples would be acceptable in the EU because the levels are not greater than 100 cfu/gm, these products would be not be acceptable in the US. Cooking would eliminate the pathogen, but the risk would arise if these items were used in a ready-to-eat application, and through preparation and storage, the organism was able to grow to higher levels.

This demonstrates the importance of control of Listeria in these types of operations. From a consumer perspective, there is the importance of following label instructions which normally requires cooking.

International Journal of Food Microbiology
https://www.sciencedirect.com/science/article/pii/S0168160520303433
Occurrence of Listeria and Escherichia coli in frozen fruit and vegetables collected from retail and catering premises in England 2018–2019

Outbreak Investigation Update - Salmonella in Red Onions - October 2020

FDA issued an update on the Salmonella outbreak associated with red onions which was first identified in July when Canadian authorities issued notice.  In the US, there were 1,127 cases with 167 hospitalizations.  The onions originated from Thompson International, which issued a recall, and that recall spurned other recalls where the onions were used in various other products.

At this point, CDC is saying that that outbreak appears over.  While FDA identified Thompson International as the source, FDA had not been able to identify any definitive reason for the contamination. 

 "FDA has completed over 2000 product and environmental analyses from multiple Thomson International Inc. locations and surrounding areas, including water, soil, and scat samples. Although a variety of genetic strains of Salmonella Newport have been detected, as well as multiple other Salmonella serotypes, a genetic match to the outbreak strain has yet to be identified in any of the samples collected. Additional sample analysis is underway. Although the outbreak is being declared over, the FDA will continue its root cause investigation and will communicate any findings that could assist future prevention efforts. "

FDA Outbreak Investigation
https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-salmonella-newport-red-onions-july-2020
Outbreak Investigation of Salmonella Newport: Red Onions (July 2020)
CDC announces the end of the outbreak; FDA continues its investigation.

Case Counts
Total Illnesses: 1,127
Hospitalizations: 167
Deaths: 0
Last illness Onset Date: September 11, 2020
States with Cases: AK (25), AL (2), AZ (39), AR (2), CA (128), CO (32), CT (2), DE (2), FL (8), GA (11), HI (3), ID (43), IL (54), IN (4), IA (31), KS (3), KY (3), ME (6), MD (7), MA (2), MI (47), MN (19), MS (5), MO (11), MT (72), NE (10), NV (11), NH (1), NJ (12), NM (3), NY (14), NC (6), ND (9), OH (11), OK (1), OR (109), PA (27), RI (3), SC (1), SD (23), TN (7), TX (2), UT (115), VA (10), WA (150), WV (3), WI (11), WY (27)