Tag: FDA Warning Letter

Pre-cooked lobster with a side order of Listeria

Greenhead Lobster Products LLC‘s (Greenhead) ready-to-eat (RTE) seafood processing facility in Bucksport, Maine, suffers from a chronic environmental contamination with Listeria monocytogenes, according to information extracted from US Food and Drug Administration’s website.

The persistent presence of the pathogen in the production environment has been known to the company and the FDA for at least the last two years.

First inspection: 2020

The FDA first visited the Bucksport facility in December 2020, issuing a list of adverse Inspectional Observations (FDA Form 483) upon completion of the inspection.

According to the agency’s inspection citations database, the FDA investigators cited four violations, including:

  • Failure to implement the monitoring procedures listed in the company’s HACCP plan;
  • Failure of the HACCP plan to list the food safety hazards that are reasonably likely to occur;
  • Failure to monitor the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including prevention of cross-contamination from insanitary objects; and
  • A corrective action plan not in accordance with regulatory requirements to ensure that a potentially hazardous product is not entered into commerce.

Second inspection: 2021

After giving Greenhead a grace period of several months to bring its food safety programs into compliance, the FDA performed a follow-up inspection in September-October 2021.

During the 2021 inspection, FDA investigators conducted extensive environmental sampling of the facilities production areas, including food-contact surfaces, and found Listeria monocytogenes in a floor drain.

Upon reviewing the company’s environmental monitoring records, the agency noted the presence of thirteen (13) recurring L. monocytogenes positive swabs between May 2021 and August 2021 from the RTE (ready-to-eat) processing room, including eleven (11) swabs collected from food-contact surfaces.

Although the company’s records indicated that the relevant areas were cleaned and sanitized following each positive finding, Greenhead did not conduct any root cause analysis to establish and eliminate the source or sources of the contamination.

Recall #1

On October 2, 2021, while the FDA inspection was still in progress, Greenhead initiated a voluntary product recall, encompassing 5,749 lbs. of frozen cooked lobster meat. The recall cited a “…potential for contamination … noted after a routine sampling program by the company revealed the presence of Listeria monocytogenes.”

Once again, the FDA issued a Form 483 upon completion of the inspection, this time classifying the situation as “Official Action Indicated.”

Warning Letter

On January 24, 2022, after exchanges of communcations regarding the company’s plans for correcting the various deviations, the FDA issued a formal Warning Letter, giving Greenhead a deadline to respond to all outstanding issues.

The Warning Letter reiterated the list of observations included in the Form 483, providing examples to support each item. These included:

  • Ongoing serious concerns with the company’s HACCP plan
  • Ongoing concerns about the company’s inability to control Listeria monocytogenes in the production environment
  • Significant deviations from requirements of the Seafood HACCP plan
  • Insufficient monitoring of sanitation conditions and practices during processing
  • Inadequate control of the hazard of Clostridium botulinum in high pressure processed (HPP) lobster products.

Third inspection: 2022

In July 2022, the FDA returned to Bucksport yet again to follow up on Greenhead’s response to the Warning Letter.

And yet again, the company’s performance was found wanting.

The Form 483 issued upon completion of the July 2022 inspection listed four main concerns:

  • Greenhead’s HACCP plan did not list the food safety hazards that were reasonably likely to occur
  • The HACCP plan listed a critical limit that failed to ensure control of one or more hazards
  • The company did not take corrective action to prevent potentially hazardous product from entering into commerce, and did not correct the cause of the deviation
  • The company was not monitoring sanitation conditions and practices with sufficient frequency to ensure compliance with current Good Manufacturing Practices.

At the close of inspection, company management agreed to make the necessary corrections and the FDA classified the results of the inspection as “Voluntary Action Indicated.”

Fourth inspection: 2023?

Recall #2

Just over one year later, on October 20, 2023, Greenhead announced another voluntary product recall, this time encompassing “…all frozen and refrigerated cooked lobster meat products produced from May 9, 2023, through October 19, 2023.”

The reason given for the recall was the presence of Listeria monocytogenes in the production environment.

Although the environment was contaminated, the pathogen was not found in finished products, and there were no illnesses associated with the recalled products.

The recall encompassed eleven ready-to-eat, refrigerated or frozen lobster products. Please refer to the recall notice for a detailed list of affected products.

The recall notice made no reference to the FDA. Nor has the FDA posted information on a 2023 inspection in its Inspection Citations database.

Nevertheless, past experience suggests that another follow-up inspection is either still in progress or has been completed recently.

What next for Greenhead Lobster Products?

Although constituted as a regulatory agency, the FDA has a history and a philosophy of giving the food companies it regulates multiple chances to self-correct.

Sometimes, this works well. Other times, it does not.

Greenhead has now been inspected on at least three (and possibly four) separate occasions, and its HACCP and sanitation programs were found wanting each time.

The FDA has the power to demand compliance (via a Warning Letter), to mandate recalls (when circumstances demand), and even to shut down a facility by suspending its registration.

Except for the issuance of a Warning Letter, the agency rarely makes use of these regulatory powers.

Will Greenhead prove to be one of those rare occasions, or will the FDA sit on its hands until one or more illnesses are linked to the company’s products?

Stay tuned.

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Cronobacter in infant formula: getting to the “root” of the problem

On August 30, 2023, the US Food and Drug Administration (FDA) issued formal Warning Letters to three manufacturers of powdered infant formulas: ByHeart, Inc., Reckitt/Mead Johnson Nutrition, and Perrigo Wisconsin, LLC.

That same day, the FDA released the redacted content of those Warning Letters to the public.

The letters reflected the agency’s concern that the companies had not established “ …a system of process controls covering all stages of processing that was designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment…”

According to the information contained in the Warning Letters, all three companies had a history of Cronobacter sakazakii contamination in the production environment, with occasional positive finished product samples. And all three companies failed, in the FDA’s estimation, to conduct a thorough “root cause analysis” to determine and correct the source of their contamination issues.

Case-by-case overview

Although the general conclusions reached by FDA investigators were similar for all three companies, each situation presented its own challenges. 

ByHeart, Inc. 

The FDA conducted its inspection of ByHeart’s Pennsylvania manufacturing subsidiary from December 21, 2022, through February 17, 2023. The operation, located at 61 Vanguard Drive, Reading, PA, manufactured an infant formula base product that was subsequently blended and packaged at a third-party contract manufacturing facility.

In October 2022, the company learned that a powdered infant formula product manufactured during a continuous production campaign at the facility from July 13, 2022, through August 23, 2022 and blended and packaged from September 15, 2022 through October 7, 2022, had tested positive for Cronobacter sakazakii.

The company’s “root cause analysis” blamed the positive result on lab error on the part of a third-party laboratory. A detailed review of the laboratory’s protocols and records found no basis to support such a conclusion.

A separate infant formula base mix that was manufactured on August 24, 2022, also tested positive for the pathogen.

This contamination event was blamed on a failure to follow specified cleaning and sanitation procedures following maintenance work and valve repair. 

Cronobacter sakazakii also was found in multiple locations in the production environment from July 25, 2022 through August 27, 2022, all of which were attributed to “…isolated events such as facility repairs, using an ineffective sanitizer, or ineffective cleaning frequency.”

In it’s Warning Letter, the FDA emphasized that the company’s root cause analyses were inadequate and did not get to the root of the problems. For example, ByHeart could have—should have, in the agency’s opinion—carried out whole genome sequencing (WGS) on the various Cronobacter sakazakii cultures in order to determine whether or not the same strain was consistently present in the production plant.

Perrigo Wisconsin, LLC

The FDA’s inspection of Perrigo’s Eau Claire, Wisconsin, manufacturing facility took place from March 6 through April 26, 2023.

On four separate occasions prior to and during the FDA inspection, the company found Cronobacter sakazakii in samples of its spray-dried infant formula manufactured during the period from October 2022 through April 2023.

The company blamed the contamination variously on probable cross-contamination betwen the dryer environment and the product contact equipment, packaging line downtime due to multiple scoop jams during production, and potential contamination introduced into the packaging line during increased dry cleaning interventions.

The FDA took exception to Perrigo’s root cause analysis in each case, pointing out that the company had not thoroughly investigated the source of the contamination. In addition, the agency expressed its disapproval of the company’s sanitation protocols and practices, stating:

“The detection of C. sakazakii in your facility across multiple independent inspections is significant in that it demonstrates your sanitation procedures have been inadequate to significantly minimize or prevent the presence of C. sakazakii in your facility.”

Reckitt/Mead Johnson Nutrition

The FDA Warning Letter detailed outstanding issues at two separate manufacturing plants: Zeeland, Michigan (inspected from February 7, 2023, through February 23, 2023) and Wanamingo, Minnesota (inspected from November 28, 2022 through January 9, 2023).

As was the case for Perrigo and ByHeart, FDA investigators found evidence of multiple reports of Cronobacter sakazakii in both finished products and environmental swab samples at both manufacturing plants

The FDA was once again unhappy with the manufacturer’s response to the Cronobacter-positive findings, stating, “Upon receiving notification of this result, you failed to conduct an independent root cause analysis or investigation and you did not evaluate whether other products may have been impacted by this contamination event.”

Root cause analysis

Cronobacter sakazakii is a common presence in the environment, and can be found in soil, surface water, mud, grains, rotting wood, bird droppings, and food. 

The microbe is relatively harmless to most people, but can cause severe illness, often leading to death in susceptible individuals, especially in preterm, low-birthweight, immunocompromised, and/or infants under than 28 days of age.

It is, therefore, incumbent upon manufacturers of powdered infant formulas to take every possible step to ensure that their products are not contaminated with this potentially dangerous microbe.

In principle, any finding of Cronobacter sakazakii in the production environment or finished infant formula should trigger what is known as a “root cause analysis”—a systematic and intensive effort to find the source of the contamination and to make the necessary corrections before proceeding with additional production.

In practice, what ByHeart, Mead Johnson, and Perrigo did was to treat the symptoms rather than diagnose and correct the problem.

For example, in some instances, the companies responded to the finding of Cronobacter by performing an intensive cleaning and sanitizing without first carrying out environmental sampling to determine where in the production or packaging environment the microbe was lurking.

The sanitation effort provided a temporary solution, but did not prevent a recurrence of the contamination. Effectively, this approach treated the symptoms, rather than eliminating the source(s) of the contamination.

In its trilogy of Warning Letters, the FDA emphasized that a proper root cause analysis must be comprehensive and complete in order to be of value in determining the source of a contaminant. 

Only once the source has been identified correctly can a long-term, effective solution to the problem be put into effect.

What next for infant formula safety?

In its August 30, 2023, news release announcing the Warning Letters, the FDA pledged its commitment to ensuring the safety of powdered infant formula, stating,

“The FDA will continue its regulatory oversight and engagement with industry to enhance infant formula safety, including continuing to conduct annual inspections of infant formula facilities, maintaining a dialogue with infant formula manufacturers on these issues, and furthering prevention-based research and activities.”

It behooves all manufacturers of powdered infant formula to do their part to maintain safe and sanitary production environments and to take all precautions necessary for the production of pathogen-free products, especially as these products are destined for the nourishment of a highly susceptible population.

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“Reads like a true crime novel” – Food Safety News

Interested in learning more about food safety and the history of foodborne disease outbreaks and investigations?

Click on the link to listen to a short excerpt, then follow the buy links to add a digital, print or audio copy to your personal library.

Chapter 6. Birth of a Pathogen

TAINTED is available in digital format from all major on-line retailers. Press the button to go directly to your preferred digital bookstore.

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Darwin’s drags feet on pet food recall request—again

Arrow Reliance, Inc., doing business as Darwin’s Natural Pet Products (Darwin’s), has delayed acting on a request from the US Food and Drug Administration (FDA) to initiate a recall of three Salmonella-contaminated raw pet foods.

This information is contained in an August 16, 2023 FDA Advisory cautioning pet owners not to feed their pets certain lots of Darwin’s Natural Pet Products raw cat and dog food.

The FDA issued its advisory out of concern that pet owners might feed the contaminated products to their pets, warning that the Salmonella-contaminated products, “…pose a significant risk to human and animal health.”

The following three products, all of which have tested positive for Salmonella, were listed in the FDA notice:

  • Darwin’s Natural Pet Products Natural Selections Chicken Recipe with Organic Vegetables for Dogs, Lot 9774, manufactured on Jun 13, 2023.
  • Darwin’s Natural Pet Products Natural Selections Chicken Recipe for Cats, Lot 9795, manufactured on Jun 28, 2023.
  • Darwin’s Natural Pet Products Natural Selections Chicken Recipe for Cats, Lot 9830, manufactured on Jul 19, 2023.

Not for the first time

Darwin’s has a troubled history dating back as far as 2016 with both the FDA and the Washington State Department of Agriculture (WSDA).

in 2016, the WSDA found Salmonella in a sample of a Darwin’s raw dog food.

In 2017, the FDA found both Salmonella and Listeria monocytogenes in a sample of Darwin’s dog food after a consumer complained that the product had made her dog ill.

In 2018, the FDA alerted the public to a “pattern of contamination” in Darwin’s raw pet foods after the agency found Salmonella, Listeria monocytogenes, and E. coli O128 in samples of the company’s products.

During a multi-day inspection of the company’s manufacturing facility in 2018/2019, the FDA found Salmonella and Listeria monocytogenes in the production environment, and also recovered Salmonella from finished product samples.

In 2022, in a follow-up to yet another consumer complaint, the FDA found two different Salmonella serotypes in samples of a Darwin’s cat food.

The inspections conducted in 2017/2018 and in 2022 both resulted in the issuance of a formal Warning Letter to the company.

In its response to the 2022 Warning Letter, obtained in response to a Freedom of Information Act request, the company simply refused to correct any of the violations listed in the letter.

Voluntary recalls and FDA Cautions/Advisories

In 2016/2017, Darwin’s quietly recalled several products, advising its customers of the recalls via direct email messages.

In March 2018, the company recalled four additional products after the FDA found Salmonella, Listeria monocytogenes, and/or E. coli O128 in samples of the items.

However, Darwin’s has not always been compliant with the FDA’s recall requests. As a result, the agency has released a total of four Cautions or Alerts for pet owners, including the most recent Advisory issued on August 16, 2023.

  • February 13, 2018:- FDA Investigates Pattern of Contamination in Certain Raw Pet Foods Made by Arrow Reliance Inc., Including Darwin’s Natural Pet Products and ZooLogics Pet Food
  • March 26, 2019:- FDA Cautions Pet Owners Not to Feed Their Pets Three Lots of Darwin’s Natural Pet Products Raw Dog Food Due to Salmonella
  • August 5, 2022:- FDA Cautions Pet Owners Not to Feed Certain Lots of Darwin’s Natural Pet Products Due to Salmonella
  • August 16, 2023:- FDA Advisory: Do Not Feed Certain Lots of Darwin’s Natural Pet Products for Dogs & Cats Due to Salmonella

What will happen next?

The FDA has multiple enforcement tools in its arsenal. However, the most effective ones also tend to be the most difficult to implement.

When the FDA classified the results of its 2022 inspection at Darwin’s as “Official Action Indicated,” the tool it turned to was a formal Warning Letter, in which it set out a list of the violations observed during the course of the inspection and the company’s (lack of) substantive response to the requested corrections. The agency gave Darwin’s the standard fifteen (15) business days in which to respond with either proof of corrections or a written plan for making them.

Darwin’s simply declined to comply.

As this most recent FDA Advisory demonstrates, the Warning Letter was completely ineffective.

Mandatory Recall

The FDA has the authority under the Food Safety Modernization Act to mandate a recall of a contaminated product that it believes to represent a hazard to human or animal health. It has exercised this authority sparingly over the years, preferring to obtain voluntary compliance on the part of a manufacturer.

Mandating a recall is not a trivial exercise. It requires several administrative steps, and can only be undertaken with the approval the FDA Commissioner, and after the company has been given written notice and one last chance to initiate a voluntary recall. At any stage in the administrative/notification process, there is a risk that the company will choose to seek an injunction to block the FDA’s action.

Suspension of Federal Food Facility Registration

Under the Food Safety Modernization Act, all food facilities under the FDA’s jurisdiction must register with the FDA and renew their registration every two years.

The FDA has the authority to suspend a food facility’s registration, effectively shutting down its activities, if, “…food manufactured, processed, packed, received, or held by a registered food facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals…”

While this would appear to be a very effective tool, Darwin’s has never registered with the FDA as a food facility, claiming that its direct sales business model and the fact that it does not distribute through a third party exempts the company from this requirement.

As indicated in the 2022 Warning Letter, the FDA disagrees with the company’s interpretation.

Request For Injunction—The Nuclear Option

When a company demonstrates a pattern of behavior that flouts the laws and regulations under which every member of its industry is required to operate and declines repeatedly to comply with those laws, the ultimate tool in the regulatory arsenal is to petition the Court to order compliance.

The FDA was forced to follow this path in 2021 when faced with egregious acts of non-compliance on the part of Bravo Packing, Inc., a New Jersey-based producer of raw foods for companion animals and exotic (zoo) animals.

This is a costly and time-consuming process, and is viewed by the agency as a last resort.

What Darwin’s customers need to know

The FDA Advisory offers the following advice to pet owners who may have purchased one of the recalled products.

  • If you have any of the Darwin’s Natural Pet Products Natural Selections cat or dog foods listed above, stop feeding it to your pets and throw it away in a secure container where other animals, including wildlife, cannot access it. 
  • Consumers who have had this product in their homes should clean refrigerators/freezers where the product was stored and clean and disinfect all bowls, utensils, food prep surfaces, pet bedding, litter boxes, toys, floors, and any other surfaces that the food or pet may have had contact with. Clean up the pet’s feces in places where people or other animals may become exposed. Consumers should thoroughly wash their hands after handling the product or cleaning up potentially contaminated items and surfaces.

How to report a pet illness

There is no animal equivalent to the CDC. There is no mandatory reporting of animal illnesses. The FDA relies on voluntary reporting of pet illnesses by pet owners and veterinarians in order to spot potential outbreaks of animal illnesses due to contaminated pet food.

People who think their pets have become ill after consuming contaminated pet food should first contact their veterinarians. Veterinarians who wish to have pets tested for Salmonella may do so through the Veterinary Laboratory Investigation and Response Network (Vet-LIRN Network) if the pet is from a household with a person infected with Salmonella. 

The FDA encourages consumers to report complaints about pet food products electronically through the Safety Reporting Portal or by calling their state’s FDA Consumer Complaint Coordinators.

TOXIC

From Factory To Food Bowl
PET FOOD IS A RISKY BUSINESS

Learn more about the history behind the current Darwin’s issues, as well as the successes and failures of other pet food companies in the production of pathogen-free raw pet foods in TOXIC: From Factory To Food Bowl, Pet Food Is a Risky Business.

Available from all major on-line retailers, including:

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Enjoy the slideshow as you listen to a sample of TOXIC, narrated by the author.

“A complete and compelling account of the hidden and not-so-hidden ways the food we give our beloved pets can be contaminated.” – JoNel Aleccia, Health Reporter, Food & Nutrition, The Associated Press.