Rushing to Judgment on the FDA 483 Inspectional Observations of Onion Facility

It can be difficult in determining the exact cause of a foodborne illness outbreak, even for inspectors.  But it seems that it can be too easy to jump to conclusions, especially for the media, based upon pieces of information that become available.  A recent posting from Food Safety Strategy titled The Mischaracterization of a 483  provides a good analysis of the FDA's 483 report of Inspectional Observations and how they can be difficult to judge, especially for those who are not familiar with food observations.  While this analysis did not reference a specific 483 report, I immediately thought of the report of the facility that was responsible for the 2024 E. coli outbreak linked to sliced onions sold at McDonalds.

To read through this, one can easily say the inspector is leaning to environmental contamination issue due to lack of cleaning.  Certainly some of the media conveyed that thought.  However, while this facility had 'potential' issues based upon what he inspector observed, there is no hard evidence provided and plenty of questions that are not answered.

As pointed out in the article cited above, fresh operations are going to have pooling water.  It is a wet operation.  The 483 cites 'apparent biofilm',  but there was no analysis to determine if it was bacteriological in origin.  In fact, no environmental testing was mentioned in the report.   

The presence of Listeria and other pathogens in these types of facilities is going to happen.  There needs to be recognition of whether that contamination is endemic or transient.

It is important to recognize that this is a process with no lethality / kill step.  The biggest issue with contamination is just as much or more of a raw material issue than a facility issue.  And the 483 does not delve into this fact that contamination may likely have been on the product.  And there has been some research evidence for internalization of pathogenic organisms in produce including onions that are grown in soil.  

Not to argue with what the inspector observed, but one must be cautious about jumping to conclusions based upon these observations without additional information including field testing, product testing, etc.

https://www.koaa.com/news/covering-colorado/inspectors-find-dozens-of-violations-at-taylor-farms-in-colorado-springs
FDA 483 Inspectional Observations
Taylor Farms Colorado, Inc.

6th &  Kipling St. (P.O. Box 25087)

Denver, CO 80225-0087

(303)236-3000  Fax:(303)236-3100

OBSERVATION 1
You did not implement your sanitation preventive control, monitoring, corrective action and verification procedures.

NC Raw Pet Food Company Continues to Issue Recalls For Pathogens Found by State Testing

Blue Ridge Beef, of Statesville, NC is recalling 5,700 lbs. of their 2 lb log Natural Mix due to a contamination of Salmonella. Lot # N25/12/31 (Lot numbers are stamped in the clips on the end of the chubs/bags) UPC# 854298001054.  Samples of the product was collected on 01/08/25 by the North Carolina Department of Agriculture and tested by the North Carolina Department of Agriculture Food and Drug Protection Laboratory. The product tested positive for Salmonella.  On 01/27/2025 the firm was notified by the FDA that the product tested positive for Salmonella.

This company has a significant history of recalling product due to the presence of pathogens.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/blue-ridge-beef-issues-recall-blue-ridge-beef-natural-mix-due-salmonella-contamination
Blue Ridge Beef Issues a Recall of Blue Ridge Beef Natural Mix Due to Salmonella Contamination
Summary
Company Announcement Date:  January 31, 2025
FDA Publish Date:  January 31, 2025
Product Type:  Animal & Veterinary  Food & Beverages   Pet Food
Reason for Announcement: Salmonella contamination
Company Name:  Blue Ridge Beef
Brand Name:  Blue Ridge Beef
Product Description:  Natural Mix

Baby Teething Chew Stick Recalled and Discontinued After Choking Incidents

Gerber Products Company is initiating a recall and discontinuation of all batches of GERBER® SOOTHE N CHEW® TEETHING STICKS due to a potential choking hazard for babies and young children.  The recall was initiated after receiving consumer complaints of choking incidents. To date, one emergency room visit has been reported to the firm.

Consumers who may have purchased GERBER® SOOTHE N CHEW® TEETHING STICKS should not feed this product to their child and can return the product to the retailer where it was purchased for a refund. Anyone concerned about an injury or illness should contact a health care provider.

According to the Gerber website, This voluntary recall and discontinuation is isolated to GERBER® SOOTHE N CHEW® TEETHING STICKS – STRAWBERRY APPLE and GERBER® SOOTHE N CHEW® TEETHING STICKS – BANANA. It does not impact any other Gerber products such as Gerber® Teethers Gentle teething wafers and Gerber® TEETHER WHEELS.

It seems to me that this product design would be a bad idea.  Anyone with a dog knows that chew sticks can be an issue with choking for some dogs, so the same issue would apply to this.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gerber-products-company-announces-recall-and-discontinuation-all-batches-gerberr-soothe-n-chewr
Gerber Products Company Announces Recall and Discontinuation of All Batches of Gerber® Soothe N Chew® Teething Sticks Due To Choking Hazard
Summary
Company Announcement Date:  January 31, 2025
FDA Publish Date:  January 31, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Potential choking hazard for babies and young children
Company Name:  Gerber Products Company
Brand Name:  Gerber
Product Description:  Gerber® Soothe N Chew® Teething Sticks

Chocolate Covered Pretzels Recalled for Undeclared Milk

United Natural Trading LLC, Edison, NJ, is voluntarily recalling Fresh Direct Dark Chocolate Covered Pretzels due to the presence of an undeclared milk allergen.  The issue was discovered during an internal review of label management system as an action item from an internal nonconformance.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/united-natural-trading-llc-announces-allergy-alert-undeclared-milk-fresh-direct-dark-chocolate
United Natural Trading LLC Announces Allergy Alert for Undeclared Milk in Fresh Direct Dark Chocolate Covered Pretzels
Summary
Company Announcement Date:  January 30, 2025
FDA Publish Date:  January 30, 2025
Product Type:  Food & Beverages  Snack Food Item
Reason for Announcement:  Undeclared milk
Company Name:  United Natural Trading LLC
Brand Name:  Fresh Direct
Product Description:  Dark Chocolate Covered Pretzels

Some Media Headlines on Recalls Do Nothing More than Cause Confusion and Fear

Reading the daily headlines, I find that these new releases for recalls are just over the top.  Today, an article titled Why Lay’s Potato Chip Recall Was Elevated To FDA’s Deadliest Category was published in Forbes online.  To read this, you are thinking that these are some truly dangerous chips.  But then when actually read the article, you realize this is an milk allergen issue (and there were people affected) with the recall occurring over a month (Dec 18, 2024) ago and that product's distribution was limited to Oregon and Washington state.

As the recall category be classified Class 1, this is more of just an administrative function that sometimes takes longer to get applied.  So not like FDA had a revelation a month later.

From the FSPCA manual, Preventive Controls for Human Foods

Recalls are actions taken by a facility to remove a product from the market that may be adulterated, misbranded, or violate regulations in some way. In other words, a product for which the FDA or a state could take legal action against the facility would be subject to a recall. It is important to note that a recall is different from a market withdrawal and stock recovery. In a market withdrawal, it is the  company’s removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the FDA, or which involves no violation. A stock recovery is when the company corrects or removes a product where that product has not left direct control of the facility.

 The numerical designation (i.e., I, II, or III) [is] assigned by FDA to a particular product recall to indicate the relative degree of health hazard presented by the product being recalled (FDA Hazard Guide, Chapter 14, 2018).

(1) Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death (21 CFR 7.3(m)(1));

(2) Class II is a situation in which use of, or exposure to, a violative product may cause temporary or

medically reversible adverse health consequences or where the probability of serious health

consequences is remote (21 CFR 7.3(m)(2)); and

(3) Class III is a situation in which use of, or exposure to, a violative product is not likely to cause illness or injury (21 CFR 7.3(m)(3)).

https://www.forbes.com/sites/stephaniegravalese/2025/01/28/why-lays-potato-chip-recall-was-elevated-to-fdas-deadliest-category/
Forbes
Why Lay’s Potato Chip Recall Was Elevated To FDA’s Deadliest Category

Three Importers Issued Warning Letters for Failure to Develop FSVP for Imported Foods

Food imported into the United States must meet same standards as products produced in the United States.  The Foreign Supplier Verification Program (FSVP) is a regulation that must be complied with by importers of food into the US.   This ensures that someone here in the US has verified compliance of the foreign producer to US standards.  However, there has been a continuing issue where importers do not comply.    And this is not that they have a bad program, it is that they have no FSVP program.

Premium Fresh Growers LLC of McAllen, Texas did not develop an FSVP for any of the foods imported, including each of the following foods:
Limes imported from, (b)(4)
Cilantro imported from, Carlos Alberto Toto Cortes, located in Mexico
Carrots imported from, (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/premium-fresh-growers-llc-698646-12182024

Candymar Produce Inc of McAllen, TX did not develop an FSVP for any of the foods imported, including each of the following foods:
Carrots imported from (b)(4)
Squash imported from (b)(4)
Cabbage imported from (b)(4).
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/candymar-produce-inc-697780-12042024

George Food Specialties Inc. of Ballston Lake, NY did not develop an FSVP for any of the foods imported. Including each of the following foods:
Mayonnaise imported from (b)(4) located in (b)(4)
Mayonnaise imported from (b)(4) located in (b)(4)
Hot Sauce imported from (b)(4) located in (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/george-food-specialties-inc-697738-12232024

FDA Warning Letter to UT Bakery Highlights Preventive Control and GMP Misses Typical for Bakery

FDA issued a Warning Letter to Salt City Baking Company of Murray, Utah,  a baking company that produces ready-to-eat (RTE) bread products.  In the Preventive Controls for Human Foods training, these topics are covered, including the need to address controls associated with exposed RTE foods.

First the company "did not conduct a hazard analysis to identify and evaluate a known or reasonably foreseeable hazard to determine whether it required a preventive control for your RTE bread products."

• Did not consider environmental pathogens, such as Salmonella, as a known or reasonably foreseeable hazard to determine whether it required a preventive control. [The] facility manufactures RTE bread products (such as White Cottage sliced bread) which are exposed to the environment after baking and handled by employees prior to packaging. 
• In addition, when contamination with environmental pathogens is a hazard requiring a preventive control, [one] must verify the effectiveness of this preventive control by performing environmental monitoring for an environmental pathogen or for an appropriate indicator organism, by collecting and testing environmental samples (see 21 CFR 117.165(a)(3)). [The company is] not performing environmental monitoring to evaluate the effectiveness of  sanitation practices regarding employee practices and cleanliness of food-contact surfaces.
• Did not consider mycotoxins as a known or reasonably foreseeable hazard to determine whether it required a preventive control. [The] bread products (such as White Cottage sliced bread) contain wheat flour, which has been associated with mycotoxins such as deoxynivalenol (DON). Therefore, contamination with mycotoxins is a known or reasonably foreseeable hazard.
• A facility that identifies raw materials and other ingredients that require a supply-chain-applied control, such as mycotoxins, must establish and implement a risk-based supply-chain program for those raw materials and ingredients (see 21 CFR 117.405(a)(1)). The supply-chain program must include using approved suppliers and conducting supplier verification activities (see 21 CFR 117.410).
• The written allergen preventive controls do not include procedures, practices, and processes for ensuring protection of food from allergen cross-contact, including during storage, handling, and use; and for food labeling to ensure the food is not misbranded 
• The written Preventive Controls document indicates that the hazard of allergen cross-contact will be significantly minimized or prevented through scheduling and segregation practices. However, the allergen preventive control procedures do not cover sesame, nor do they include preventive control management components (monitoring, verification, and corrective action) for any allergens (see 21 CFR 117.140).
• In addition, the bread products are packaged in plastic bags and then the bags are placed into a cardboard case for distribution for use by foodservice establishments. The finished product labels are applied to the outside of the cardboard case. We note that you did not have adequate controls in place for undeclared allergens regarding monitoring and verification activities.

GMP Issues

USDA Issues Health Alert for Chicken Nugget Product for Potential Bone Fragments

The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert for frozen, fully cooked Wegmans breaded chicken breast nuggets that may be contaminated with extraneous material, specifically bone fragments. FSIS is issuing this public health alert to ensure that consumers are aware that this product should not be consumed. A recall was not requested because the product is no longer available for purchase.  The product was produced on August 26, 2024.  FSIS was notified of the issue after Wegmans received multiple consumer complaints of bone fragments in the frozen fully cooked breaded chicken breast nugget product.


https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-wegmans-frozen-fully-cooked-chicken-nuggets-due
FSIS Issues Public Health Alert for Wegmans Frozen Fully Cooked Chicken Nuggets Due to Possible Extraneous Material Contamination

Perdue Foods LLC

FSIS Announcement

WASHINGTON, Jan. 27, 2025 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert for frozen, fully cooked Wegmans breaded chicken breast nuggets that may be contaminated with extraneous material, specifically bone fragments. FSIS is issuing this public health alert to ensure that consumers are aware that this product should not be consumed. A recall was not requested because the product is no longer available for purchase.

California Firm Recalls Bread Crumbs for Undeclared Sesame

La Fiesta Food Products, LLC, La Mirada, CA is recalling 8 oz packages of La Fiesta brand Unseasoned Bread Crumbs (Pan Rayado) and Seasoned Bread Crumbs (Pan Rayado Sazonado). The products contain sesame as an undeclared allergen. Additionally, the labels do not include the allergen declaration in Spanish.  The recall was initiated after discovering that the product contained undeclared sesame. Further investigation revealed that the issue was caused by errors on the product labeling.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/recall-la-fiesta-brand-bread-crumbs-unseasoned-and-seasoned-undeclared-sesame
Recall of La Fiesta Brand Bread Crumbs (Unseasoned and Seasoned) for Undeclared Sesame
Summary
Company Announcement Date:  January 25, 2025
FDA Publish Date:  January 28, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared allergen (sesame)
Company Name:  La Fiesta Food Products, LLC.
Brand Name:  La Fiesta
Product Description: Breadcrumbs (pan Rayado)