Tag: Arrow Reliance

Darwin’s QA program evolves in response to FDA enforcement measures

The following story by Phyllis Entis first appeared in Food Safety News and is reposted here with permission.

Arrow Reliance Inc., dba Darwin’s Natural Pet Products, is taking steps to correct multiple violations of the Federal Food, Drug, and Cosmetic Act discovered during an investigation of Darwin’s raw pet food manufacturing facility in December 2017 and January 2018.

The Food and Drug Administration detailed the problems in a warning letter April 2.

A redacted copy of Darwin’s response letter was obtained by Food Safety News in response to a Freedom of Information Act request.

The investigation was triggered by a series of product recalls announced by the company in late 2017 due to Salmonella contamination in samples of Darwin’s raw frozen pet foods, following customers’ complaints of a kitten death and other ill pets. The joint investigation was carried out by the FDA and the Washington State Department of Agriculture (WSDA).

The FDA warning letter, and the Establishment Inspection Report that preceded it, highlighted several issues, including:

  • Bacterial pathogens (Salmonella, Listeria monocytogenes and/or E. coli O128) present in samples of various Darwin’s Natural Selections and ZooLogics brands of raw pet food;
  • The identical strain of Salmonella was recovered from both the dead kitten and a sample of food that had been fed to the kitten;
  • The protocol used by Darwin to reduce pathogen contamination through the application of bacteriophages had not been validated;
  • Failure to conduct operations under cGMPs (current Good Manufacturing Practices)
  • Raw materials not thawed under conditions that would minimize potential for growth of undesirable pathogens;
  • Animal food contact surfaces not made of appropriate materials or maintained to protect animal food from becoming contaminated; and
  • Equipment and utensils not used appropriately to avoid adulteration of animal food with contaminants.

In its response to the FDA warning letter, Darwin officials reported conducting a risk assessment to identify the root cause or causes of contamination. Based on the results of their assessment, the company concluded that the primary source of their contamination problem was pathogens present in some raw materials. 

To address that issue, Darwin has adopted new approaches to reducing or eliminating pathogens in those raw materials, including:

  • Requiring all meat suppliers and produce suppliers to use a pathogen-reducing treatment (details redacted) prior to shipping raw materials;
  • On-site audits of meat suppliers and primary produce supplier;
  • Pathogen testing conducted by an independent testing lab of a number of inbound raw materials;
  • Additional “interventions” that are being evaluated (details redacted) for possible inclusion in the company’s processes to further reduce pathogen levels;
  • Increasing the dosage of bacteriophages to match the manufacturer’s “standard” recommended dosage and tested a revised method of application; and
  • Conducting validation tests, which were carried out by an independent testing lab, to confirm the effectiveness of the higher bacteriophage dosage and revised application method.

According to Darwin’s response letter, in 2016, the company hired a Quality Assurance (QA) manager who developed the company’s first formal Standard Operating Procedures (SOPs) and Sanitation Standard Operating Procedures (SSOPs) and expanded the company’s sanitation and environmental testing programs. Prior to 2016, the sanitation and quality assurance functions were handled by the production department.

In response to the violations detailed in the FDA warning letter, the company expanded its QA team, adding an assistant manager and technicians. It also conducted a comprehensive review and update of its Good Manufacturing Practices (GMPs) conducted training sessions for employees, and corrected other issues raised by FDA and WSDA inspectors during the inspections initiated in December 2017 and completed in January 2018.

When asked to comment on the remedies outlined in Darwin’s response letter, a spokesperson for FDA said “… we aren’t able to share … any information about discussions with firms regarding their responses to warning letters.”

FDA’s investigation remains open, according to the agency spokesperson.

FDA gives Darwin’s pet food owners 15 days to clear up issues

Adulterated pet food, dead kitten, use of unapproved additive spur FDA warning letter

The FDA issued a formal warning letter to Arrow Reliance Inc. doing business as Darwin’s Natural Pet Products, citing pathogen problems at a production plant and saying scientific evidence shows the company’s cleaning solution is ineffective.

Darwin’s is a manufacturer of raw pet foods and is based in Tukwila, WA.

The April 2 warning letter from the Food and Drug Administration cites a history of consumer complaints and product recalls leading to the agency’s analysis of several Darwin’s products. Laboratory tests detected Salmonella, Listeria monocytogenes and E. coli O128 in one or more samples of the pet foods.

Foods under FDA jurisdiction, including pet foods, are deemed to be adulterated if they bear or contain a poisonous or deleterious substance that may render them injurious to health, according to the Federal Food, Drug, and Cosmetic Act (the Act). Introduction of an adulterated food into interstate commerce is a prosecutable violation of the Act.

Federal officials also found two Darwin’s products were also contaminated with Listeria innocua. Although it is not considered a pathogen in terms of human health, the warning letter underscored that the presence of Listeria innocua is an indicator that Listeria monocytogenes would be capable of surviving and growing in the product.

One of the consumer complaints that triggered the FDA investigation was lodged by the owner of a kitten that died as a result of a “severe systemic Salmonella infection” after being fed Darwin’s Natural Selections Duck Meals for Cats. 

Salmonella was isolated from the dead kitten’s liver and from an unopened raw pet food package. Whole Genome Sequencing (WGS) analysis, often referred to as genetic fingerprinting, confirmed that the Salmonella recovered from the dead kitten and from the pet food sample were identical.

FDA also performed WGS analysis on Salmonella recovered from various other Darwin’s samples. The identical Salmonella strain was found in two different products manufactured two weeks apart and containing two different meat sources. 

The presence of the identical Salmonella in these two products, according to the warning letter, suggests pathogen contamination in Darwin’s manufacturing facility.

In the letter, FDA also expressed its concern regarding Darwin’s use of a bacteriophage product to control pathogens in the raw pet foods, citing a lack of scientifically based validation of the controls and a change in the company’s protocol for applying the bacteriophage to the products.

The agency noted that the bacteriophage product is not “generally recognized as safe” (GRAS) nor is it the subject of a regulation describing additives permitted in animal foods.

The company was given 15 business days to reply to the warning letter, with a description of the steps taken to correct the violations and prevent these or similar violations from occurring in the future. 

This story first appeared in Food Safety News and is reposted here with permission.

Darwin’s pet food owner knew of pathogens in production plant

The producer of Darwin’s brand raw pet foods knew about Salmonella in its plant, fielded more than 300 consumer complaints about sick or dead pets, and racked up a laundry list of food safety violations in 2017, according to government inspectors.

Investigators from the U.S. Food and Drug Administration and the Washington State Department of Agriculture (WSDA) identified numerous problems at Arrow Reliance Inc., doing business as Darwin’s Natural Pet Products. They undertook the December 2017 inspection in response to an ongoing pattern of product recalls and a consumer complaint received in October 2017.

Gary Tashjian, president and owner of Darwin’s, told the inspectors his company hadn’t received any specific complaints regarding Salmonella, E. coli or Listeria, according to a draft report from the inspectors. He said if consumers complained of pets’ illnesses, they would have to provide Darwin’s with test results from a veterinarian before the company would test its retained samples of implicated products. Only if the retained sample also tested positive would Darwin’s initiate a recall Tashjian told inspectors.

This week Darwin’s issued its fifth product recall since October 2016 after the Food and Drug Administration found Salmonella in four of its products. One of those products also was contaminated with E. coli O128.

According to the draft inspection report, obtained from WSDA by Food Safety News through a public records request, a review of the pet food company’s own records revealed much of the information that shows Darwin’s owners were aware of the pathogen problems.

Darwin did not have a written sanitation plan at the time of the inspection, according to the draft report.

The company was performing in-house pathogen testing that included screening for Salmonella. Darwin’s logs showed the company found Salmonella on the handle of a hand cart and the wheel of a garbage can that were on the processing floor in September. There was no documentation of a repeat test after the contaminated items were cleaned.

Similarly, an Aug. 24, 2017, log entry documented failure of the trench drain by the grinder. Again, there was no mention of corrective action.

Thermometer verification logs also showed several failures, with no corrective action documented.

Inspectors reported that Darwin’s maintains a record of customer complaints. During the period from Jan. 5, 2017, through Dec. 5, 2017, the company logged 332 complaint entries, including complaints of foreign material, spoiled and leaking packages, and pet illnesses and deaths.

More than one-third of the complaints — 36 percent — related to sickness. Ten percent were for foreign objects, including metal, plastic, rubber bands, produce bands and ties, hairnet material, and a pebble.

In addition to reporting on Darwin’s records, investigators recorded the following general “objectionable” conditions:

  • Failure to conduct operations under cGMPs (current Good Manufacturing Practices);
  • Raw materials were not thawed under conditions that would minimize the potential for growth of undesirable pathogens;
  • Animal food contact surfaces not made of appropriate materials or maintained to protect animal food from becoming contaminated; and
  • Equipment and utensils not used appropriately to avoid adulteration of animal food with contaminants.

Inspectors also cited the following specifics in their report:

  • A mallet with raw meat material on it was on a rack used to store sanitized equipment in the sanitizing room;
  • 4-wheeled hand cart with two shelves covered with wet cardboard containing raw meat. Cart was touching a food preparation surface. Buckets used to carry and mix micro ingredients and phage preparation stored on the cart. Cart handle was broken and surface appeared to not be cleanable;
  • Dirty tool from processing floor placed on top of sanitized yellow pallet;
  • Food preparation table grooved and not cleanable;
  • Flashing between wall and floor and behind prep table was damaged and contained meat debris;
  • Employee observed breaking down dirty cardboard boxes with gloved hands and returning to processing floor without changing gloves or sanitizing;
  • Freezer box “B” had bloody and rusted metal racks; bloody floors and boxes storing frozen meat; organic material behind racks;
  • Cooler box “A” had bloody boxes of meat and vegetables stored on metal racks and pallets with organic material behind racks;
  • Cardboard boxes containing raw meat were observed leaking and dripping blood onto boxes stored below and onto adjacent boxes, pallets and metal racks;
  • Wooden pallets and metal racks not maintained or designed to be cleaned in a manner that protects ingredients against contamination;
  • Fork lift was observed moving from the receiving/loading dock, over the packing floor, through Box A and into the raw product prepping room;
  • Employees were wearing dirty boots in sanitation room and on process floor;
  • Damaged wall in preparation room;
  • Cement floor under hoses chipped and broken away. An approximately 12-inch x 12-inch hole was observed in first layer of cement;
  • Employee pocket knife observed on food contact service;
  • Door stops and upright pillar stops pitted and rusted;
  • Slider door between prep room and temping room rusted and dirty; and
  • Recycled wooden pallets noted in processing area at end of packing line.

FDA advice to consumers
People who think they might have become ill due to exposure to contaminated raw pet food or the feces of pets that have eaten contaminated raw pet food should talk to their health care providers.

Contact your health care provider if you have diarrhea that lasts for more than three days, or is accompanied by high fever, blood in the stool, or so much vomiting that you cannot keep liquids down and you pass very little urine.

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

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.

This story first appeared in Food Safety News and is reposted here with permission.