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.


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