April 13, 2025

During the 2024 calendar year, Morasch Meats, Inc. (Portland, OR) sold dozens of batches of Northwest Naturals raw pet foods and pet treats after the finished products tested presumptive-positive for Salmonella or Listeria monocytogenes.

Instead of confirming the presumptive result as required by the test kit manufacturer, the company repeated the same rapid test on fresh samples. When the repeat test did not find the pathogen, Morasch released the production batch for sale.

This information came to light during an Establishment Inspection performed December 27, 2024 through February 7, 2025 in response to a consumer complaint of a cat that had contracted bird flu after consuming a Northwest Naturals pet food. The Inspectional Observations report (FDA Form 483) was obtained by eFoodAlert in response to a Freedom of Information Act request.

Background

Morasch Meats, Inc. processes and packages meat for human consumption (under USDA inspection), and manufactures ready-to-eat raw pet foods and treats for dogs and cats.

In March 2018, the FDA conducted an inspection of the company’s pet food production facility in response to a finding of Listeria monocytogenes in a sample of Northwest Naturals Chicken and Salmon pet food chubs. The inspector found no objectionable conditions, and the inspection was classified as “No Action Indicated.”

In May 2024, an FDA investigator conducted an unannouced routine compliance inspection of Morasch’s pet food operations. Once again, the inspection was classified as “No Action Indicated.”

On December 20, 2024, the FDA was alerted by the Oregon Department of Agriculture (ODA) to the death (by euthanasia) of a three year old cat that had become infected with bird flu. The necropsy report summarized the diagnosis as: “severe necrotizing meningoencephalitis, bronchiolar necrosis to necrotizing bronchiolitis, and rare hepatic necrosis due to highly pathogenic avian influenza (HPAI).”

The ODA collected samples of the open package of Northwest Naturals Turkey Recipe raw cat food that had been fed to the cat. Molecular testing (PCR tests) detected the presence of Influenza A H5N1 nucleic acid in the pet food.

On December 27, 2024, the FDA initiated a new investigtion of Morasch Meat’s pet food operations. That investigation was completed on February 7, 2025.

What the FDA found

In contrast to the May 2024 plant visit, the most recent inspection revealed a pattern of sloppy labwork on the part of the company.

Standard practice when using a test kit to detect pathogens is to begin with an enrichment culture (to allow the pathogen to reach a level that can be detected by the kit).

If the enrichment culture tests negative, all is well. But, if the test kit result is positive (ie., presumptive positive), the enrichment culture is supposed to be processed through conventional test methods to confirm that positive result.

Instead, the company discarded the presumptive positive enrichment cultures in favor of repeating the test kit on a new sample from the same production lot. When the repeat samples tested negative, the company ignored the first (positive) test results and released the products for distribution.

On reviewing the company’s lab test records, the FDA investigator documented dozens of occasions during the 2024 calendar year where the company released product that had previously tested positive for Salmonella or Listeria monocytogenes. These included (quoted verbatim from the FDA Form 483):

• “At least 27 batches of frozen finished products tested [redacted] had a presumptive positive for the presence of a pathogen. The same batches were re-tested with a negative result…You explained these products were distributed into commerce without any additional processing to eliminate potential pathogens.”
• “Your finished product testing for 2024 shows at least [redacted] batches of frozen finished products were tested [redacted] with presumptive positive pathogen (Salmonella or Listeria monocytogenes) results. These batches were retested [redacted] and all [redacted] from the initial [redacted] had negative pathogen results. You explained these products were distributed into commerce.”
• “Your finished product testing for 2024 shows you had at least 109 batches of [redacted] products tested [redacted] with presumptive positive pathogen [E. coli O157:H7, Salmonella or Listeria monocytogenes) results. These batches were retested [readacted], and all [redacted] batches from the initial [redacted] had negative pathogen results. You explained these products were distributed into commerce.”

The inspector highlighted in her report that the manufacturing test kit instruction insert states, “Presumptive positive samples should be confirmed as per the laborator standard operating procedures or by following the appropriate reference method confirmation.” This instruction is consistent with standard FDA laboratory procedures as laid out in the agency’s Bacteriological Analytical Manual.

The company’s records also documented at least 20 locations in the production plant that were found to be positive for Salmonella or Listeria monocytogenes during the 2024 calendar year.

In addition to the persistent problem of pathogen contamination in the production environment and in finished products, the FDA inspection revealed several other concerns, all of which were documented in the Form 483 report. These included:

• Condensate from the ceiling and from equipment dripping directly onto ready-to-eat finished products
• Wood pallets in poor repair
• Employees moving from handling processing equipment to touching finished product without changing gloves
• Employees not washing hands
• Deep gashes and missing sections in the area of the metal chopper, with areas with direct food contact filled with product during production and between batch runs.
• Vitamin and mineral toxicities of concern were not identified in the hazard analysis
• Drug residue concerns were not identified in the hazard analysis

The company’s response

The company acknowledged the validity of the FDA’s observations in a written response in which it promised:

• “When conducting tests, we will count the first test as a positive result and not retest. We will use our validated interventions as necessary to accomplish a negative result. The product will be retested after the intervention and results will be logged.”
• “When conducting environmental sampling for pathogens and the result of a test is positive, we will conduct a corrective action to determine cause and retest to confirm results.”
• “Test procedures have been implemented to Homogenize thoroughly.”
• “Vitamin and mineral toxicity have been added to the hazard analysis at the rework step.”

Morasch’s response claimed that the various sanitation observations were addressed during the inspection.

Unanswered questions

1. During the May 2024 inspection, the FDA investigator noted that “Finished pet food product is released for distribution after microbiological analyses results are cleared.” This same investigator also reported having reviewed the environmental monitoring records for the firm’s sanitation program. How did he miss the all of those positive pathogen results?
2. Duriung the May 2024 inspection, the FDA investigator did a “walk-through” of the production plant. How did he miss the physical deficiencies (dripping condensate, etc.) that were found only a few months later by a different FDA inspector?
3. This facility is under daily oversight by the USDA. How were the physical deficiencies described in the FDA 483 report allowed to persist?

A final word

It is a food safety axiom that a negative retest does not cancel out a previous positive result on the same production batch.

Bacteria are not distributed uniformly through a solid food. Especially for low-level pathogen contamination, it is quite common for two different samples from the same batch to produce opposite results.

The use of “retest and release if negative” has been proven over and over again to be not just poor practice.

It is downright dangerous.

“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