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

FDA issue Warning Letters to the following food importers for issues involving FSVP - Foreign Supplier Verification Program. The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards.

• Jaramillo Spices Corp of McAllen, TX.id not have FSVPs for these products or any of the food products you import.   https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jaramillo-spices-corp-614760-06082021
• Mr Lukas LLC of McAllen, TX did not develop FSVPs as required for the imported foods.   https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mr-lukas-llc-613441-04092021
• Tuty Usa LLC of Conroe, Texas did not have FSVPs for these products or for any other products you import.     https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tuty-usa-llc-614625-06092021

Fresh Packed Blueberries Recalled Due to Potential Cyclospora

Dole Diversified North America, Inc. is recalling a limited number of cases of Dole™ Fresh Blueberries packaged in a variety of clamshell sizes for potential Cyclospora contamination.
This voluntary recall is due to possible Cyclospora contamination on Dole™ Fresh Blueberries. Dole Diversified North America, Inc. is coordinating closely with regulatory officials. No illnesses have been reported to date in association with the recall.  The impacted products were distributed in four US states (IL, ME, NY, and WI), and two Canadian provinces (Alberta and British Columbia).

With no reported illnesses, one could guess that this was triggered by testing.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dole-diversified-north-america-inc-announces-limited-recall-doletm-fresh-blueberries-potential
Dole Diversified North America, Inc. Announces Limited Recall of Dole™ Fresh Blueberries for Potential Cyclospora Contamination
Summary
Company Announcement Date:  June 24, 2021
FDA Publish Date:  June 25, 2021
Product Type:  Food & Beverages
Reason for Announcement:  Cyclospora contamination
Company Name:  Dole Diversified North America, Inc.
Brand Name:  Dole™
Product Description:  Fresh Blueberries

VA Company Recalls Egg-like Product for Containing Egg

Cuisine Solutions, Sterling, VA is initiating a voluntary recall of its JUST Egg flavored plant-based “bites” products due to undeclared allergens. A limited number of 2-pouch retail packages may contain an incorrect sealed pouch containing whole-egg and milk products. 

 

The egg recall occurred when a packaging error was made where product containing actual egg was put into the box.

  

From the company website, we can see this is a supplier related issue "We use third-party facilities to manufacture our products, so we cannot guarantee that our allergen-free products are made on designated allergen-free lines or in allergen-free facilities. For example, JUST Egg is egg-free but is made in a facility where egg is present. In order to lower the risk of incidental contact with allergens from other products manufactured in the same facility, we require that our third-party manufacturers employ rigorous sanitation, inspection, and good manufacturing practices."  

The label JUST Egg, but it is egg flavored and does not contain egg (not sure why it is not called NO Egg).  So what does the properly labeled product contain?

Ingredients

Water, Mung Bean Protein Isolate, Expeller-Pressed Canola Oil, Contains less than 2% of Dehydrated Onion, Gellan Gum, Natural Carrot Extractives (color), Natural Flavors, Natural Turmeric Extractives (color), Potassium Citrate, Salt, Soy Lecithin, Sugar, Tapioca Syrup, Tetrasodium Pyrophosphate, Transglutaminase, Nisin (preservative). (Contains soy.)

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cuisine-solutions-issues-voluntary-recall-flavored-plant-based-bites

Cuisine Solutions Issues Voluntary Recall of Flavored Plant-Based Bites
Summary
Company Announcement Date:  June 19, 2021
FDA Publish Date:  June 20, 2021
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared milk and egg
Company Name:  Cuisine Solutions
Brand Name:  Just Egg
Product Description:  Egg flavored plant-based “bites”
Company Announcement

CA Company Recalls Milk Powders Due to Infant-related Labeling Issue

DESIGNED BY NATURE of California is recalling Goat’s Milk Powder, Cow’s Milk Powder and Base Milk Powder formulas beacuse the labels to not make it clear that these products are not intended to be used as infant formula.

The label state Developed for all life stages, and thier website states, "Designed by Nature offers only 100% nutritious, clean, simple and wholesome formulas. Our formulas are made from real food whole ingredients that are nutritionally complete and easy to digest."

However, "The Federal Food, Drug, and Cosmetic Act (FFDCA) defines infant formula as "a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk" (FFDCA 201(z)). FDA regulations define infants as persons not more than 12 months old.  All infant formulas sold in the United States must meet the requirements of the Infant Formula Act (section 412 of the Food, Drug, and Cosmetic Act).  Designed by Nature formulas are not intended or approved for infants."


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/designed-nature-voluntarily-recalls-goats-milk-cows-milk-and-base-milk-formulas-due-possible-health
Designed By Nature Voluntarily Recalls Goat’s Milk, Cow’s Milk and Base Milk Formulas Due to Possible Health Risk
Summary
Company Announcement Date: June 14, 2021
FDA Publish Date:  June 14, 2021
Product Type:  Food & Beverages Milk/Milk Product  

Reason for Announcement:  Products are not intended to be used as infant formula
Company Name:  Designed by Nature
 Brand Name:  Designed by Nature
Product Description:  Goat Milk, Cow Milk, and Base Mix Formulas

FDA Warning Letter - Allergen Recalls Initiates Inspection of Oregon Facility

FDA issued a Warning Letter to Market of Choice, LLC  after inspecting their food manufacturing facility located in Eugene, Oregon.  The inspection was initiated as a result of a Class I recall of one of the company's products because of undeclared tree nut (almond) allergen on the product label printed and applied at the retail stores. 

Allergens

• The company did not appropriately identify undeclared allergens as a hazard requiring a preventive control in allergen-containing products.  Although the facility receives, stores, and uses allergens such as tree nuts, peanuts, milk, eggs, soy, and wheat in production, the hazard analysis indicated that the allergen hazard was not significant due to low likelihood.   [This is a common error that FDA finds...facilities think that the prerequisite programs are sufficient, but FDA is finding that this is not the case].
• The company submitted  a “New Product Label Verification Checklist” , however, this procedure for new product development does not appear to address the root cause of the recall – failure to make electronic allergen labeling revisions after reformulations that add or change the allergens in a product. In addition, the procedure does not include monitoring, corrective action, or verification procedures to ensure control of the undeclared allergen hazard.

 Other items - Of course, if FDA is there, they will conduct a broader inspection.

• The company did not appropriately identify contamination with environmental pathogens, such as Listeria monocytogenes and Salmonella for the RTE fresh salads which are exposed to the environment prior to packaging and do not receive a lethal treatment or otherwise include a control measure that would significantly minimize these environmental pathogens
• The company did not take appropriate Corrective Action  after obtaining "six Salmonella positive swab results in rooms adjacent to the main production room where ready-to-eat products are exposed to the environment prior to packaging.  The company had not established and implemented written corrective action procedures that must be taken to address the presence of an environmental pathogens.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/market-choice-llc-613557-06012021
WARNING LETTER

Market of Choice, LLC
MARCS-CMS 613557 — JUNE 01, 2021
Recipient:
Richard L. Wright Jr.
President
Market of Choice, LLC
2862 Willamette Street, Suite B
Eugene, OR 97405
United States

FDA Issues Report on Salmonella Outbreak Associated with Peaches

FDA issued a report on an August, 2020 outbreak of Salmonella Enteritidis infections linked to 

peaches packed or supplied by a large grower/producer. In total, in the U.S. there were 101 reported 

illnesses across 17 states.

• 'The traceback investigation identified multiple distributors, packing facilities, and orchards that supplied bagged and/or loose peaches during the timeframe of interest to the identified points of service, with a large grower/producer’s peaches and packing facilities supplying the majority of peaches associated with points of service during the timeframe of interest; however, a single point or source of contamination was unable to be determined by the traceback investigation.'
• 'In total, over 700 tests were conducted, including: approximately 180 tests of peach leaves and approximately 20 tests of peaches collected from multiple orchards, approximately 480 tests of environmental samples and approximately 20 tests of peach products collected from three peach packing/holding facilities, and approximately 20 tests of peach products collected from two additional distribution centers (one in Iowa and one in Illinois) for testing. While no test results matched the 2020 outbreak strain, four tests returned positives for Salmonella Alachua and two tests returned positives for Salmonella Montevideo.'
• 'Isolates from one peach test and three leaf tests, each collected from an orchard adjacent to a poultry facility, were positive for Salmonella Alachua.'
• 'Salmonella Montevideo was detected in two tests of orchard canopy leaves collected during this follow-up investigation, each collected from an orchard with adjacent or nearby cattle operations.'
  
• 'We [FDA] hypothesize that the adjacent animal operations (both poultry and cattle) were a likely contributing factor to the Salmonella Enteritidis outbreak – with fugitive dust as one possible route of product contamination. In addition, almond orchards were also identified to be in the vicinity of several identified peach orchards and almond operations have the capacity to generate significant dust due to the nature of their harvesting method in a relatively dry growing environment – as well as having the documented potential to harbor Salmonella populations'

In light of these findings, FDA encourages all farms (including growers, harvesters, etc.) to:

• Be cognizant of and assess risks that may be posed by adjacent and nearby land uses,  especially as it relates to fugitive dust exposure from adjacent or nearby livestock and poultry.
• Assess growing operations to ensure that appropriate science- and risk-based preventive  measures are in place, including applicable provisions of the FDA Food Safety  Modernization Act (FSMA) Produce Safety Rule and good agricultural practices. 
• Consider additional tools such as pre-harvest and/or post-harvest sampling and testing of  products to help inform the risk assessment and clarify the need for specific prevention  measures.
• When pathogens are identified through microbiological surveys, pre-harvest testing of  produce, or post-harvest testing of produce implement industry-led root cause analyses to  determine how the contamination likely occurred and then implement appropriate prevention and verification measures. 
• Improve traceability through increased digitization, interoperability, and standardization of  traceability records which would expedite traceback and help remove contaminated  product from the marketplace more quickly, thereby preventing further illnesses. This is  not only important for growers, but also critical for shippers, manufactures, and retailers as  well, to improve overall traceability throughout the supply chain. 

Personally, the fugitive dust guess is a bit of a stretch considering the number of cases.  There are so many factors that could have played a major role, but would have been impossible for inspectors to see at the time of inspection with time passing and operations changing.

Factors Potentially Contributing to the Contamination of Peaches Implicated in the Summer 2020 Outbreak of Salmonella Enteritidis (fda.gov)
Investigation Report: Factors Potentially Contributing to the Contamination of Peaches Implicated in the Summer 2020 Outbreak of Salmonella Enteritidis

Chick Feed Recalled Due to Deficiently Low Salt Level

Hubbard Feeds is voluntarily recalling EASY FEED ORGANIC CHICK STARTER/GROWER ORG with batch number B01785781. The product has been found to contain deficient levels of salt.   Low sodium may cause abnormal nerve impulses so chicks’ muscles will not move well. Low sodium can also affect the cell’s normal internal pressure which can affect cardiac output due to deflated muscle not working well. The growth of birds may also be negatively impacted.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hubbard-feeds-voluntarily-recalls-easy-feed-organic-chick-startergrower-org
Hubbard Feeds Voluntarily Recalls Easy Feed Organic Chick Starter/Grower Org
Summary
Company Announcement Date:  June 08, 2021
FDA Publish Date: June 08, 2021
Product Type: Animal & Veterinary
Reason for Announcement:  Contains deficient levels of salt
Company Name: Hubbard Feeds
Brand Name: Hubbard Feeds
Product Description: EASY FEED ORGANIC CHICK STARTER/GROWER ORG

Dog Food Recalled After This Deviated Product Inadvertently Is Shipped

Freshpet Inc. is announcing a voluntary recall of a single lot of Freshpet® Select Small Dog Bite Size Beef & Egg Recipe Dog Food (1 LB bags), with Sell by Date 10/30/2021,due to potential contamination with Salmonella. Our Freshpet Team had designated this single lot for destruction, but it was inadvertently shipped to retailers in limited geographic markets between June 7 to June 10, 2021.

These are those types of recalls that occur when 'held' product  inadvertently gets shipped.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/freshpet-voluntarily-recalls-one-lot-freshpetr-select-small-dog-bite-size-beef-egg-recipe-dog-food
Freshpet Voluntarily Recalls One Lot of Freshpet® Select Small Dog Bite Size Beef & Egg Recipe Dog Food Due to Potential Salmonella Contamination
Summary
Company Announcement Date:  June 13, 2021
FDA Publish Date:  June 13, 2021
Product Type:  Animal & Veterinary
Reason for Announcement:  Potential for Salmonella
Company Name:  Freshpet Inc.
Brand Name:  Freshpet
Product Description:  Select Small Dog Bite Size Beef & Egg Recipe Dog Food

Kimchi Aioli Sauce Recalled After Putting Incorrect Back Label on Bottles Resulting in Mislabeled Allergens

Tulkoff Food Products Inc. of Baltimore Maryland is recalling Kimchi Aioli 18 fl. oz. squeeze bottles with lot code 09.18.2021M for the presence of undeclared wheat and soy allergens.  The recall was initiated after Tulkoff discovered that the incorrect back label had been affixed to the product. This error was confined to one specific product, and one specific lot.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tulkoff-food-products-inc-issues-allergy-alert-undeclared-soy-and-wheat-kimchi-aioli
Tulkoff Food Products, Inc. Issues Allergy Alert on Undeclared (Soy and Wheat) in Kimchi Aioli
Summary
Company Announcement Date:  June 08, 2021
FDA Publish Date:  June 08, 2021
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Soy and Wheat Allergens
Company Name:  Tulkoff Food Products Inc.
Brand Name:  Tulkoff
Product Description:  Kimchi Aioli