FDA Warning Letter - TX Importer with No FSVP Plan

FDA issued a Warning Letter to Dulces La Mejor, LLC, of San Antonio, TX for not having a FSVP program in place for the products the company was importing.  In the Warning Letter, FDA states that the company issued a response after the initial audit stating that they received partial training and had started working on the plan.  FDA was not sufficiently satisfied because they provided no proof of progress.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dulces-la-mejor-llc-615986-09152021
WARNING LETTER
Dulces La Mejor, LLC
MARCS-CMS 615986 — SEPTEMBER 15, 2021

FDA Warning Letter - Processor of Cashew Cheese-like ProductThat Was Linked to Salmonella Outbreak

FDA inspected a facility producing imitation cheese product after that product was linked to a Salmonella outbreak.  In that outbreak, raw cashews had been identified as the source, but from the Warning Letter, the company had additional issues.

"According to CDC, as of July 7, 2021, 20 people from 4 states have been infected with the outbreak Salmonella serotypes. Four of the same Salmonella serotypes (Urbana, Leiden, Vinohrady and Chester) were also found in an environmental swab taken from your vegan cashew brie (b)(4) during FDA’s inspection, your vegan cashew brie varieties, and/or your incoming cashew pieces used to manufacture your vegan cashew brie products. CDC and FDA have determined, based on the epidemiologic and laboratory evidence, that the RTE vegan cashew brie products produced at your facility are the likely source of the multi-state Salmonella outbreak."

The company felt that receiving a COA for the cashews was sufficient, but without the supplier actually controlling Salmonella, a test will not determine low levels of contamination.  And with inadequate cleaning as identified in the Warning Letter, those low levels of Salmonella can be disseminated in the product.

"The COA provided appears to be for a different lot of cashew pieces than the subject lot referenced above from which FDA isolated Salmonella Urbana ((b)(4) vs (b)(4)). Further, your response references FDA‘s draft guidance2, “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals,” in regard to use of a COA. That draft guidance states that “[t]esting of . . . the food produced by the supplier may be an appropriate supplier verification approach if such testing provides meaningful results relating to control of a hazard requiring a control.” (Emphasis added). However, your supplier was not controlling the hazard of Salmonella in the raw cashews; therefore, it was not appropriate for you to rely on testing (as reported on the COA) to address the Salmonella hazard. Because the hazard of Salmonella was not controlled by your supplier, it was necessary for you to control the hazard."

Finally, this company had been classified for purposes of the Preventive Controls regulation as a Modified Facility, that is, the facility would need to have GMPs and identified controls, but not have a formal Preventive Controls plan.  This is the downside of this aspect of the regulation - not having to put effort into determining how to identify and put in the necessary controls in place.  FDA indicated that the facility may be forced to withdraw from the Modified Facility status.  Hopefully that occurs.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jules-foods-615218-10192021
WARNING LETTER
Jule's Foods
MARCS-CMS 615218 — OCTOBER 19, 2021

Salad Products Recalled After Brown Plastic Pieces Found in Supplied Ingredient

Ukrop’s Homestyle Foods is recalling salad products after discovering brown plastic in one of the ingredients supplied to them.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ukrops-homestyle-foods-announces-voluntary-recall-six-green-salads-and-chicken-caesar-wrap
Ukrop’s Homestyle Foods Announces Voluntary Recall Six Green Salads and Chicken Caesar Wrap
Summary
Company Announcement Date:  October 21, 2021
FDA Publish Date:  November 01, 2021
Product Type:  Food & Beverages
Reason for Announcement:  May contain small pieces of brown plastic
Company Name:  Ukrop’s Homestyle Foods
Brand Name:  Ukrop's
Product Description:  Green Salads and Chicken Caesar Wrap

Taylor Farms Recalls Mushroom Stir Fry Due to Listeria

Taylor Farms is recalling Mushroom Stir Fry due to the potential for Listeria.  There was no information was posted regarding how the contamination was determined.  At this point, all the product is likely past the expiration date.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/taylor-farms-mushroom-stir-fry-9-oz
Taylor Farms Mushroom Stir Fry, 9 Oz.
Summary
Company Announcement Date:  October 23, 2021
FDA Publish Date:  October 23, 2021
Product Type:  Food & Beverages
Reason for Announcement:  Listeria monocytogenes
Company Name:  Taylor Farms
Brand Name:  Taylor Farms
Product Description:  Mushroom Stir Fry
Company Announcement  Affects Kroger stores located in Georgia; South Carolina; Auburn, Alabama, Greater Louisville area (including Indiana) and Lexington, Kentucky; Greater Memphis area, Tennessee; Arkansas; Mississippi; Western Kentucky; Nashville and Knoxville, Tennessee.

Ingredient Supplier Issue with Metal Fragments Results in Recall of Tastykake Cupcakes

Updated Nov. 3.  Additional products added to recall.

Flowers Foods, Inc. (NYSE: FLO) is recalling Tastykake multi-pack cupcakes due to the potential presence of tiny fragments of metal mesh wire. The recall was initiated following notification by a vendor of the possible contamination in a supplied ingredient.

This is an issue often discussed...supplier control of potential metal fragments.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amended-flowers-foods-issues-voluntary-recall-certain-tastykake-products-due-possible-presence-tiny

Amended – Flowers Foods Issues Voluntary Recall on Certain Tastykake Products Due to Possible Presence of Tiny Fragments of Metal Mesh Wire

Bagged Garden Salad Recalled After State Laboratory Finds Listeria in a Sample

Dole Fresh Vegetables, Inc. is voluntarily recalling a limited number of cases of garden salad due to a possible health risk from Listeria monocytogenes.   The product being recalled is now past its expiration date.   This precautionary Recall notification is being issued due to a single sample of garden salad which yielded a positive result for Listeria monocytogenes in a random sample test conducted by the Department of Agriculture in Georgia.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dole-fresh-vegetables-announces-precautionary-limited-recall-garden-classic-salads-possible
Dole Fresh Vegetables Announces Precautionary Limited Recall of Garden Classic Salads for Possible Contamination with Listeria monocytogenes
Summary
Company Announcement Date:  October 29, 2021
FDA Publish Date:  October 29, 2021
Product Type:  Food & Beverages Produce  
Reason for Announcement:  Potential contamination with Listeria monocytogenes
Company Name:  Dole Fresh Vegetables, Inc.
Brand Name:  Dole & others
Product Description:  garden salad

Canada - Mushrooms Recalled for Listeria After CFIA Testing

Canada - Carleton Mushroom is recalling Sliced White Mushrooms prepared for Metro Brands from the marketplace due to possible Listeria monocytogenes contamination.  This recall was triggered by Canadian Food Inspection Agency (CFIA) test results.  There have been no reported illnesses associated with the consumption of this product.

Canadian Food Inspection Agency
https://inspection.canada.ca/food-recall-warnings-and-allergy-alerts/2021-10-25/eng/1635207961753/1635207968501
Food Recall Warning - Sliced White Mushrooms prepared for Metro Brands recalled due to Listeria monocytogenes
Recall date:  October 25, 2021
Reason for recall:  Microbiological - Listeria
Hazard classification:  Class 1
Company / Firm:  Carleton Mushroom
Distribution:  Ontario, Possibly National, Quebec
Extent of the distribution: Consumer 

Company Experiences Another Recall Due to Allergens After Wrong Packaging Used

Bobo’s of Boulder, Colorado is issuing a voluntary recall of Bobo’s 4-Pack Almond Butter Protein Bars because they may contain undeclared peanuts.  The company became aware of the issue after "a consumer notification about an allergic reaction, the recall was initiated after it was discovered that product containing peanuts was distributed in packaging that did not reveal the presence of peanuts on the ingredient deck. This has been the only consumer notification to date."

You may recall that Bobo's issued a recall in March of 2021 when they essentially had the same issue -"The recall was initiated after it was discovered that product containing peanuts was distributed in packaging that did not reveal the presence of peanuts on the ingredient deck."  Yep....Bobo's had two booboos.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bobos-issues-voluntary-allergy-alert-undeclared-peanuts-almond-butter-bars
Bobo’s Issues a Voluntary Allergy Alert on Undeclared Peanuts in Almond Butter Bars
Summary
Company Announcement Date:  October 27, 2021
FDA Publish Date:  October 27, 2021
 Product Type:  Food & Beverages
Reason for Announcement:  Contain undeclared peanuts
Company Name:  Bobo’s
Brand Name:  Bobo’s
Product Description:  Almond butter bars

Hummus Product Recalled for Allergen Issue After Wrong Side Label Applied

Cedar’s Mediterranean Foods, of Ward Hill, MA is voluntarily recalling Cedar’s Organic Mediterranean Hummus 10 oz. because it may contain an incorrect back label and undeclared allergen (Pine Nut).  Cedar’s initiated the recall when it was discovered that a mislabeled container failed to scan at the point of sale.

This has been a common issue leading to allergen recalls - mismatched labels on the product.  One label is correct, but the label with the ingredient statement is incorrect.  In this case the side label does not broadly state the product name as the top label does, making this a harder error to catch through simple visual examination.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cedars-mediterranean-foods-issues-allergy-alert-undeclared-pine-nut-10-oz-organic-mediterranean
Cedar’s Mediterranean Foods Issues Allergy Alert on Undeclared Pine Nut in 10 Oz. Organic Mediterranean Hommus
Summary
Company Announcement Date:  October 25, 2021
FDA Publish Date:  October 25, 2021
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared pine nut
Company Name:  Cedar’s Mediterranean Foods
Brand Name:  Cedar’s
Product Description:  Organic Mediterranean Hommus