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

Chicago Kimchi Operation Receives a Deserved Warning Letter

FDA issued a Warning Letter to 5,000 Years Foods of Chicago IL, a company that produces kimchi.  Basically,  the company downloaded some record keeping logs from the internet to make it look like they had controls in place, but between the lack of real controls and a slew of GMP issues that made this far to much to provide in a short summary.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/5000-years-foods-inc-617797-01272022
5,000 Years Foods, Inc.

FDA Issues Warning Letter to Dairy Powder Packer with Serious Salmonella Contamination Issues in Facility

FDA issued a Warning Letter to OFP ingredients after an inspection of their tolling operation for dry milk powder processing located in Oconomowoc, Wisconsin.  The facility processes agglomerated milk powders that are sold for further blending into beverages or for further packaging, and are considered RTE because they are consumed without further processing to significantly minimize biological hazards.  
 

The biggest concern was that FDA found Salmonella on environmental samples which demonstrated a lack of control.  "FDA laboratory analysis confirmed 10 of 174 environmental swabs collected were positive for Salmonella Cubana. Of these positive findings, three positive swabs were collected from the (b)(4) room, a room that you consider a primary pathogen control area where products are exposed to the environment and include the following locations: a crack in the wall and floor junction adjacent to (b)(4); the floor and stair junction of the mezzanine level which employees climb to access ribbon blenders; and the floor drain cover adjacent to the mezzanine stairs. Additionally, three positive swabs were collected from the agglomeration room, including the equipment framework under Line (b)(4)."

Further, this Salmonella strain was determined to be a resident organism.  Again, FDA - "Whole genome sequencing (WGS) was conducted on the Salmonella isolates obtained from the 2021 FDA environmental samples, and the current WGS analysis determined that the 2021 isolates matched isolates from three other environmental samples including FDA sample 437365, FDA sample 892439, and FDA sample 940886, which were collected from this facility location in 2009, 2016, and 2017, respectively. The presence of the same strain of Salmonella over multiple years indicates there has been a resident pathogen in your facility since at least 2009."

The facility was trying to control the environment through prerequisite programs rather than establishing this as a Sanitation Preventive Control.  The company's own environmental testing program had found salmonella, but they never did sufficient corrective action to eliminate the organism.  In addition, GMP issues seemed to be spreading the organism (fork lifts with positive samples on the wheels).

History has shown that facilities with this level of contamination will be hard pressed to rid itself of this resident Salmonella.


https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ofp-ingredients-llc-617124-12072021

OFP Ingredients LLC

MARCS-CMS 617124 — DECEMBER 07, 2021

Iowa Creamery Issued Warning Letter for Not Knowing How to Label Food Products Properly

FDA issued a Warning Letter to Picket Fence Creamer of Woodward, Iowa after finding twelve flavors of ice cream and three flavors of cheese curds contained undeclared ingredients and sub-ingredients.  From the notice, the company failed to identify ingredients and also failed to detail the makeup of certain ingredients (listing the sub-ingredients).  Makes you wonder if they were controlling allergens from product to product.

While a small farm producer, they were distributing their food items to retail stores.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/picket-fence-creamery-llc-618726-01142022
Picket Fence Creamery LLC

MARCS-CMS 618726 — JANUARY 14, 2022

FDA Issues Warning Letter to LA Seafood Company for Not Having HACCP Plan

FDA issued a Warning Letter to D&C Seafood of Venice, LA for not have a HACCP plan in place for thier seafood products - 1) king mackerel and wahoo to control the food safety hazards of histamine formation, 2) king mackerel and barracuda to control the hazard of ciguatera toxin, and 3) king mackerel, wahoo, barracuda, and cobia to control the hazard of undeclared allergens.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dc-seafood-inc-617675-09152021
WARNING LETTER
D&C Seafood, Inc

MARCS-CMS 617675 — SEPTEMBER 15, 2021

Imported Enoki Mushrooms Recalled After State Laboratory Finds Listeria

Golden Medal Mushroom Inc. of Los Angeles, CA is recalling all cases of its 200g/7.05-ounce packages of Enoki Mushrooms, lot # 300511, product of China, because it has the potential to be contaminated with Listeria monocytogenes.  The potential for contamination was discovered after routine testing by Michigan Department of Agriculture and Rural Development revealed the presence of Listeria monocytogenes in 200gram package of Enoki mushroom.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/golden-medal-mushroom-inc-recalls-enoki-mushrooms-because-possible-health-risk-0
Golden Medal Mushroom Inc. Recalls Enoki Mushrooms Because of Possible Health Risk
Summary
Company Announcement Date:  February 03, 2022
FDA Publish Date:  February 04, 2022
Product Type:  Food & Beverages
Reason for Announcement: Listeria Monocytogenes
Company Name:  Golden Medal Mushroom Inc.
Brand Name:  Golden Medal Mushroom Inc.
Product Description:  Enoki Mushrooms

CT Firm Recalls Ice Cream After FDA Sampling Finds Listeria on Equipment

The Royal Ice Cream Company, Inc. of Manchester, CT is recalling specific lots of Batch Ice Cream Brand Vanilla, Ginger, and Mocha Chip Ice Cream, because it has the potential to be contaminated with Listeria monocytogenes.  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."

At this point, one day code comprising 3 products are being recalled.  Would not be surprised to see this recall expand, especially since the problem has not yet been identified.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/royal-ice-cream-company-inc-recalls-batch-ice-cream-brand-vanilla-ginger-and-mocha-chip-ice-cream
The Royal Ice Cream Company, Inc. Recalls Batch Ice Cream Brand Vanilla, Ginger, and Mocha Chip Ice Cream Because of Possible Health Risk
Summary
Company Announcement Date:  February 04, 2022
FDA Publish Date: February 04, 2022
Product Type: Food & Beverages
Reason for Announcement: Listeria Monocytogenes
Company Name:  The Royal Ice Cream Company, Inc.
Brand Name:  Batch Ice cream
Product Description:  Vanilla, Ginger, and Mocha Chip Ice Cream

Three Companies Recall Salted Plum Products Due to Lead Contamination

EL CHAVITO, INC. of San Diego, CA is recalling all lots of Saladitos Dried Salted Plums and Saladitos Enchilados Salted Plums With Chili because while La Fiesta Food Products, La Mirada California is recalling all lots of Saladitos Con Chile(Salted Plums with Chili) and A&E Corrales LLC, Seattle, WA is recalling Saladitos Dried Salted Plums With Chili because these products have the potential to be contaminated with lead.

No reason on how the lead was detected or where it originated.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/el-chavito-inc-recalls-saladitos-dried-salted-plums-and-saladitos-enchilados-salted-plums-chili
El Chavito, Inc. Recalls Saladitos Dried Salted Plums and Saladitos Enchilados Salted Plums with Chili Because of Possible Health Risk

Summary

Company Announcement Date:  February 03, 2022

FDA Publish Date:  February 03, 2022

Product Type:  Food & Beverages

Reason for Announcement:  potential to be contaminated with lead

Company Name:  EL CHAVITO, INC.

Brand Name:  El Chavito®

Product Description:  Saladitos Dried Salted Plums and Saladitos Enchilados Salted Plums With Chili

Salad Dressings Recalled for Undeclared Egg

Conagra Brands, Inc. (NYSE: CAG), is voluntarily recalling a limited amount of Wish-Bone Thousand Island and Chunky Blue Cheese dressings due to egg in the product, which is not declared on the product label.  While there was no reason stated for how the error was identified or how it occurred, both products do contain egg yolk so it is likely that the wrong back label was applied.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/conagra-brands-issues-voluntary-allergy-alert-undeclared-egg-wish-boner-thousand-island-and-chunky
Conagra Brands Issues Voluntary Allergy Alert on Undeclared Egg in Wish-Bone® Thousand Island and Chunky Blue Cheese Dressings
Summary
Company Announcement Date:  January 28, 2022
FDA Publish Date:  January 31, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared egg
Company Name:  Conagra Brands, Inc.
Brand Name:  Wish-Bone
Product Description:  Salad dressings

Consumer Reports - Test Results for Frozen Produce

Consumer Reports released their testing results of frozen produce.  Nothing special to report regarding pathogens or nutrient quality.  Their testing did not yield any pathogenic bacteria.  Which we would generally expect.   From a nutrient perspective, they found that frozen is generally comparable to fresh.

That being said, it is always important to follow proper handling and preparation procedures.  From time to time, we can encounter contamination issues, such as with Listeria.  While the study did not look for viruses or parasites, and although a low risk, these too have been found.  https://www.cdc.gov/parasites/cyclosporiasis/outbreaks/foodborneoutbreaks.html

https://www.consumerreports.org/food-safety/are-frozen-fruits-and-vegetables-healthy-and-safe-a1002196402/
Are Frozen Fruits and Vegetables Healthy and Safe?
CR tested more than 300 samples of frozen produce for bacteria that commonly cause foodborne illness

"For our tests, we looked for E. coli, listeria, and salmonella, types of bacteria that commonly cause foodborne illness, in eight frozen categories—avocado, berries, corn, mangoes, peaches, pineapple, spinach, and smoothie mixes. In total, we included 369 items from big brands, private label, and store brands, including 365 by Whole Foods, Blendtopia, Birds Eye, Campoverde, Dole, Great Value, O Organics, and Trader Joe’s."