Federal and state inspectors observed numerous problems with manufacturing processes during a 2016 visit to the Tukwila, WA, manufacturing facility of Arrow Reliance Inc., doing business as Darwin’s Natural Pet Products.

The regulators’ ability to take action was limited because the company was not yet required to comply with current Good Manufacturing Practices (CGMP) under the Food Safety Modernization Act (FSMA), according to a report by the Washington State Department of Agriculture (WSDA) and obtained by Food Safety News through a Public Records Request.

State inspectors worked with federal inspectors from the Food and Drug Administration on the case. However, without documentation of product adulteration, they could not act.

There are several ways FDA is able to support a finding of adulteration of an animal food under the Food, Drugs and Cosmetics Act (FD&C), according to a spokesperson for FDA, including demonstration of a “poisonous or deleterious substance” in a particular food, demonstration that the food was prepared under insanitary conditions, or demonstration that the food is unfit, based on scientific test results, available scientific literature and expert opinion.

The 2016 FDA/WSDA joint inspection was triggered by a consumer complaint of foreign objects, specifically plastic, metal and bone shards, in multiple packages of Darwin Natural selecions premium dog food.

According to information Food Safety News obtained from WSDA, the consumer contacted the Illinois Department of Agriculture (IDOA) and FDA after having lodged several complaints with the company without having obtained a satisfactory response.

Illinois officials forwarded the complaint to WSDA on June 8, 2016.

FDA and WSDA inspected Darwin’s manufacturing plant over a period of four days, June 22-30, 2016.

During the June 22 and 23 visits to the plant, inspectors observed that a metal detector was not working consistently, and the company did not maintain a maintenance/calibration log for the metal detector.

Inspectors also observed liquid leaking from boxed meat products that were stored on wooden pallets in the cooler.

During the inspection, samples of two products were collected by the WSDA inspector for pathogen analysis. The WSDA detected Salmonella agona in a sample of Darwin’s Natural selecion Duck with Organic Vegetables, Meals for Dogs, Lot code 3077, manufactured on June 22.

On July 29, 2016, Darwin officials agreed to destroy and dispose of the contaminated product. No recall was considered necessary, as none of the product had been shipped to customers.

The 2016 report referring to “numerous GMP-type issues” is consistent with information obtained by Food Safety News from an individual who was employed by Darwin in 2015.

Speaking under conditions of anonymity, the former employee described a reluctance on the part of company management to engage in developing and implementing food safety programs, including a sanitation program, environmental swabbing and HACCP.

As of May 31, 2017, Darwin still did not have a written Food Safety Plan, according to WSDA.

A spokesman for the company told Food Safety News on Monday that the firm is “actively updating” its Food Safety Plan in advance of this year’s Sept. 17 deadline for compliance with FSMA.

The company also has replaced the wooden pallets in its warehouse with plastic pallets, is calibrating its metal detectors “regularly” and is continuously testing its packaging materials, according to the spokesperson.

Darwin’s former employee alleges the company’s consumer complaint log did not reflect all of the complaints received, including items such as animals passing bones; plastic material in the products; and sick animals.

The company’s spokesman told Food Safety News that Darwin’s customer service staff addresses customer concerns on a “case-by-case basis.” He did not reply when asked whether Darwin conducts any routine microbiological testing of its ingredients or finished products prior to shipment.

Situations that were serious enough to warrant a product recall were ignored by management, according to the former Darwin employee, who says the company would only initiate a recall if a customer’s veterinarian documented beyond doubt the existence of a contaminant.

A review of product recalls initiated by the company since the 2016 inspection showed that each one resulted from a consumer complaint lodged with the company and/or with FDA, according to the following information provided by FDA.

Recall initiated Jan. 17, 2016 – Darwin received a customer complaint that a dog became ill after consuming one of their products. In response, the firm tested several products and found that they were contaminated with Listeria monocytogenes. Darwin recalled the three products found to be contaminated.

Recall initiated Aug. 9, 2017 – Darwin received a customer complaint that a kitten became ill and died after consuming the raw cat food Natural selecions brand frozen raw Duck Meals for Cats Lot #38277. A necropsy was performed on the dead kitten. The veterinary lab submitted animal tissues and product for culture and Salmonella was found. Independently, Darwin submitted a sample of the implicated pet food to a contract lab. The product was recalled after the contract lab reported finding Salmonella in the pet food sample.

Recall initiated Oct. 4, 2017 – A dog owner reported to FDA that her dog became ill after consuming a variety of Darwin’s Natural Selections Raw Dog Foods, particularly the beef variety. FDA collected four samples of these foods, and two of the four samples were preliminarily positive for Salmonella. One additional sample was preliminarily positive for both Salmonella and Listeria monocytogenes. Darwin recalled all three products.

Recall initiated Feb. 10, 2018 – FDA received a consumer complaint in which a pet owner described ongoing sickness in her dog while feeding Darwin’s raw pet food products. FDA collected three intact samples from the pet owner, and found that two tested positive for Salmonella. Darwin recalled the two Salmonella-positive products.

Foodborne pathogens such as Salmonella and Listeria monocytogenes can cause serious, and sometimes fatal, infections in pets and the people who handle their food. Bowls, utensils, surfaces such as counters and floors, and peoples’ hands or clothing can harbor the dangerous bacteria.

Regarding the apparent increase in Salmonella contamination problems during the past six months, the company spokesman said at the time of the most recent recall, “… over 99 percent of the product had already been consumed by pets, but less than 1 percent of our customers had any issues. Of these, most were relatively minor conditions such as diarrhea.”

When asked what additional information Darwin wished to share with pet owners, the company spokesman said, “Our number one priority is providing pets with meals that are healthy and safe.”

“Our customers know that feeding raw is a very healthy way for pets to eat,” he added, “and we are committed to continuously improving all aspects of our products to make them the healthiest alternative for pets.”

Darwin uses a bacteriophage (phage) antimicrobial treatment in its manufacturing process, and claims to have conducted validation tests that showed the process to have reduced pathogens, including Salmonella, to non-detectable levels.

However, a 2017 review article published in the Journal of Microbiology and Biotechnology referred to several attempts to apply phages to Salmonella control in meats and poultry. Those efforts left, in general, 10 percent of Salmonella alive. Also, phage treatment was most effective when used in combination with other control methods, according to the authors of the review article.

FDA’s investigation of the “pattern of contamination” in Darwin’s pet foods is ongoing. The agency reminds consumers that pets may carry Salmonella without displaying symptoms of illness, and can pass the infection to humans without the animals being visibly ill.

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