Inspection results show Arrow Reliance (Darwin’s) is a repeat offender

Observations recorded by FDA investigators during an August 26—September 18, 2024, inspection of the Arrow Reliance Inc. (Darwin’s Natural Pet Products) pet food production facility in Tukwila, Washington reveal that the company has failed to correct siginificant food-safety violations, some of which date back to 2018.

This information was obtained by eFoodAlert in response to a Freedom of Information Act request.

The repeat offenses

Darwin’s has not identified and implemented adequate controls to ensure that any hazards requiring a preventive control are significantly minimized or prevented (repeat observation from inspection conducted in 2023)

As evidence, FDA investigators cited:

Six finished product samples confirmed to contain Salmonella, one of which also contained Listeria monocytogenes
Lack of documentation to support use of peroxyacetic acid to control Listeria effectively
Employees not following the company’s written procedures for conducting swabbing to verify effectiveness of cleaning and sanitizing in production room

Operations not conducted in accordance with current good manufacturing practices; adequate precautions not taken to prevent contamination of food or to conduct manufacturing under conditions to protect against contamination (repeat observation from inspection conducted in 2018)

FDA investigators cited multiple examples, including:

The peroxyacetic acid additive used by Darwin’s to control pathogens in its raw, ready-to-eat pet foods is not been used in a manner consistent with the ingredient labeling and is not generally recognized as safe for use in animal food
During a sanitation shift, aerosolized waster was being blown throughout the room and onto exposed ready-to-eat product on the uncovered packaging line and in an open hopper
Aerosolized water from a sink hose was blowing throughout the room where exposed product was being prepared for rework
An employee was handling multiple items, including soiled paper towel, filler hose, and finished product without changing gloves or cleaning them in a hand dip
Water from a hose was spraying onto boxed ingredients staged for production

The company had not maintained food contact surfaces to protect food from being contaminated (repeat observation from inspection conducted in 2018)

FDA investigators observed the following:

White plastic cutting board portion of meat prep table contained deep cut marks that appeared to remain discolored even after cleaning and sanitation
A grinder used to grind raw meat and poultry ingredients appeared damage, with numerous gouges and scratches throughout
A blade housing with visible apparent rust
Several parts stored on shelving units appeared pitted, damaged or rusty even after cleaning and sanitizing. These parts were considered by the company to be clean and ready for use

Additional observations

Maintenance issues

The floor through the production room appeared damaged and pitted. There was an accumulation of water, blood, and raw ingredients across the floor during production.
There was damage around the entire base of a pillar near the meat prep table, with accumulation of water, blood, and raw ingredients in the crevaces. Thawed, boxed raw proteins for processing are staged against this pillar.

Design deficiencies

Plant was not constructed or designed to facilitate cleaning, maintenace and pest control
Visible condensation and apparent dust build-up on the production room ceiling, including over the uncovered packaging line
Drops of condensate observed falling from the ceiling into clean/sanitized vemag carts (wheeled bins used to move bulk product and ingredients from place to place in the plant)

HACCP plan deficiencies

Company did not identify drug residues associated with incoming raw meat and poultry as a known or reasonably foreseeable hazard
Company did not identify specific vitamin/mineral toxicities and deficiences of concern for dogs and cats as a known or reasonably foreseeable hazard for those pet foods manufactured and labeld as “complete diets”

Pathogens

Finished product testing

On August 27, 2024, the FDA sampled six finished products for pathogen testing. The samples were collected from Darwin’s third-party cold storage facility. Salmonella was recovered from all six products. In addition, Listeria monocytogenes was found in one of the products. A second species of Listeria (L. innocua) was found in one product.

Natural Selections Antibiotic & Grain-free CHICKEN RECIPE FOR CATS, Lot No. 10832:- Salmonella detected
Natural Selections Antibiotic & Grain-free CHICKEN RECIPE FOR CATS, Lot No. 10856:- Salmonella detected
Natural Selections Antibiotic & Grain-free CHICKEN RECIPE FOR CATS, Lot No. 10890:- Salmonella detected
Natural Selections Antibiotic & Grain-free CHICKEN RECIPE FOR DOGS, Lot No. 10828:- Salmonella and Listeria monocytogenes detected
Natural Selections Antibiotic & Grain-free CHICKEN RECIPE FOR DOGS, Lot No. 10844:- Salmonella detected
Natural Selections Antibiotic & Grain-free CHICKEN RECIPE FOR DOGS, Lot No. 10887:- Salmonella and Listeria innocua detected

Environmental testing

FDA collected 63 environmental swab samples during the course of the inspection and submitted these for Listeria monocytogenes analysis. No Listera were found in any of the 63 environmental samples.

FDA collected 101 environmental swab samples during the course of the inspection and submitted these for Salmonella analysis. Salmonella Typhimurium was found in one of the swab samples.

What next for Arrow Reliance/Darwin’s?

The FDA has classified the results of this inspection as “Official Action Indicated.” This can mean anything from a Warning Letter up to and including legal action to halt the company’s operations until it complies with FDA regulations.

On two past occasions—in April 2018 and February 2023—the FDA has issued Warning Letters citing a long list of violations. These have been totally ineffective.

Pet families can only hope that the FDA will take a firmer hand this time around.

“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.

“An invaluable resource for busy pet owners” – Food Safety News

Available from all major on-line retailers, including:

FDA advises pet owners against feeding certain Darwin’s Natural Selections pet foods

The US Food and Drug Administration (FDA) is advising pet owners not to feed certain Darwin’s Natural Selections chicken-based raw pet foods to their dogs and cats.

The warning came after the FDA found Salmonella in three lots of the company’s dog food and three lots of cat food.

One of the lots also was contaminated with Listeria monocytogenes.

The FDA’s advisory specifies the following products, all of which are sold in frozen 2-pound packages:

Darwin’s Natural Selections Antibiotic & Grain-Free Chicken Recipe for Cats
- Lot No: 10832 MFG. Date: Jul 25, 2024
Darwin’s Natural Selections Antibiotic & Grain-Free Chicken Recipe for Cats
- Lot No: 10856 MFG. Date: Aug 04, 2024
Darwin’s Natural Selections Antibiotic & Grain-Free Chicken Recipe for Cats
- Lot No: 10890 MFG. Date: Aug 13, 2024
Darwin’s Natural Selections Antibiotic & Grain-Free Chicken Recipe for Dogs
- Lot No: 10828 MFG. Date: Jul 24, 2024
Darwin’s Natural Selections Antibiotic & Grain-Free Chicken Recipe for Dogs
- Lot No: 10844 MFG. Date: Jul 30, 2024
Darwin’s Natural Selections Antibiotic & Grain-Free Chicken Recipe for Dogs
- Lot No: 10887 MFG. Date: Aug 12, 2024

The FDA has recommended that the manufacturer, Arrow Reliance, Inc. (Tukwila, WA) recall the six contaminated production lots. The company has not yet done so.

Arrow Reliance, Inc., has a long history of disagreements with the FDA regarding the significance of Salmonella and Listeria monocytogenes in raw pet food. In February 2023, the company received a formal Warning Letter from the FDA, citing several unresolved issues following an inspection of the manufacturing facility.

What should consumers do?

If you have any of the Darwin’s Natural Selections pet food product listed above, stop feeding the product to your pets and throw it away in a secure container where other animals, including wildlife, cannot access it. Do not donate the food.

The product lot codes are printed on the front of the lower left unit of the package of food. If you no longer have the package or can’t read the lot code, throw the food away.

Consumers who have had the products listed above in their homes should clean and disinfect all pet supplies, including all storage containers, 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, including your refrigerator or freezer. 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.

What’s the big deal?

Pet foods contaminated with Salmonella and L. monocytogenes are of particular public health importance because they can affect both human and animal health. Pets can get sick from Salmonella and may also be carriers of the bacteria and pass it on to their human companions without appearing to be ill.

The FDA is aware of cases in which humans and/or animals have gotten sick from exposure to Salmonella-contaminated pet foods. Although FDA is not aware of a documented case of a person acquiring L. monocytogenes infection from a pet food, once Salmonella or L. monocytogenes get established in the pet’s gastrointestinal tract, the animal can shed the bacteria in the feces when it has a bowel movement, and the contamination may continue to spread. It is important to clean up the animal’s feces in yards or parks where people or other animals may become exposed, in addition to cleaning items in the home.

The Federal Food, Drug, and Cosmetic Act requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled. Refrigeration or freezing does not kill Salmonella or L. monocytogenes.

How to report a pet illness

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 and L. monocytogenes 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 or L. mono.

The FDA encourages consumers to report complaints about pet food products electronically through the Safety Reporting Portal. Additionally, consumers can visit the SmartHub – Safety Intake Portal – Report a Product Problem (fda.gov) to obtain electronic assistance with submitting a report.

“An invaluable resource for busy pet owners” – Food Safety News

Available from all major on-line retailers, including:

Darwin’s to customer: Salmonella-contaminated food “is fine”

In September 2023, an employee of Arrow Reliance, Inc. (doing business as Darwin’s Natural Pet Products) assured a consumer that Darwin’s Natural Pet Products Natural Selections Chicken Recipe for Cats (Lot 9830, manufactured on Jul 19, 2023), was “fine,” even though the US Food and Drug Administration (FDA) had advised the public the month before that the batch in question was contaminated with Salmonella.

The consumer contacted the company after their cat was diagnosed with a Salmonella infection, according to documents obtained by eFoodAlert in response to a Freedom of Information Act request.

The consumer discarded the unused portions of the cat food and on September 14, 2023, filed a Pet Food Report with the FDA’s Center for Veterinary Medicine.

In response to a separate complaint, filed a few days earlier, the FDA collected an unused portion of Darwin’s Natural Pet Products Natural Selection Chicken Recipe for Cats (Lot code unknown) from the home of a consumer in a different state. The consumer reported that all four of their cats developed gastrointestinal problems after having consumed the product.

The FDA lab found two different Salmonella serotypes (Typhimurium and Hadar) in the sample.

Company aware of contamination

In August 2023, the FDA conducted the latest in a series of investigations into conditions at the Darwin’s Tukwila (Washington State) manufacturing facility.

On August 11, 2023, at the completion of their inspection, FDA investigators presented the company’s owner, Gary Tashjian, with a list of outstanding issues (FDA Form 483, Inspectional Observations). These observations included:

The detection of Salmonella in three different products, manufactured on June 13, June 28, and July 19, 2023.
Use of an unvalidated process as a preventative control for pathogens in the products over a four-month time span.
Lack of documentation that the preventative control process was carried out.

When the company declined to recall the three Salmonella-positive product batches, the FDA issued an Advisory to pet owners, cautioning them to avoid feeding the potentially hazardous batches to their pets.

In a written response to the list of observations, the company asserted (not for the first time) that it was a “…Retail Food Establishment and therefore … not subject to the provisions in the Food Safety Modernization Act which require a food safety plan and preventive controls.”

Notwithstanding this assertion, the company arranged for an independent lab to test retained samples from the implicated products, and reported that their lab found “only trace amounts” of Salmonella in just one of the batches identified by the FDA.

Darwin’s also claimed that the unvalidated process was a “temporary substitution” for its usual, validated process, was initiated as a result of an equipment failure, and that the company had since reverted to the validated process.

Finally, the company reported that it had initiated proper documentation of its preventative control process in response to the FDA’s final observation.

Fraught history

The relationship between Arrow Reliance (Darwin’s) and the FDA has been fraught with discord and disputes almost since the initial inspection of the company’s facilities in 2016. The story is told in some detail in TOXIC: From Factory To Food Bowl, Pet Food Is a Risky Business. More recent chapters in the evolution of Darwin’s relationship with the FDA can be found by entering “Darwin” in the eFoodAlert search box at the top of the page (right hand side).

Do your part to support pet food safety

The FDA relies heavily on reports from consumers and veterinarians to highlight possible pet food safety issues. If you suspect that a pet food or pet treat has caused your furry or feathered companion to become ill, please report your concerns to the FDA.

Pet owners can report suspected illness to FDA electronically through the Safety Reporting Portal or by calling your state’s FDA Consumer Complaint Coordinators. It’s most helpful if you work with your veterinarian to submit a pet’s medical records as part of the report. For an explanation of the information and level of detail that would be helpful to include in a complaint to FDA, please see How to Report a Pet Food Complaint.