As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.

A pet food company in Oregon is on notice from the FDA after inspectors found Listeria monocytogenes in the manufacturing facility. This warning letter serves as a reminder that pet food products can contain dangerous pathogens and should be handled as carefully as other products.

Consumers should beware of cross contamination from pet food on surfaces, such as kitchen counters. Contamination in pet food can make people sick when cross contamination occurs or when good handwashing and other hygiene practices are not followed.  

Raw Advantage Processing LLC
Aumsville, OR

In an Aug. 18 warning letter, the FDA described Aug. 26 and 30 inspections at Raw Advantage Processing LLC’s pet food manufacturing facility. The inspectors found that the firm had significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Food for Animals regulation. 

In response, the FDA issued the firm a  Form FDA 483.

The significant violations:

1. The firm failed to identify and evaluate each known or reasonably foreseeable hazard for each type of animal food manufactured, processed, packed, or held at their facility to determine whether there are any hazards requiring a preventive control.

The firm provided FDA investigators with a document titled “Raw Advantage Processing hazard analysis raw, ground product for (redacted) Processing” and another titled, “Raw Advantage Processing hazard analysis raw, ground product – with and without ingredients” for (redacted) products as part of their food safety plan. FDA review determined that neither of these documents identifies and evaluates all the known or reasonably foreseeable hazards for animal food in their facility.

1. The firm’s written hazard analysis for their raw ground pet food products that do not undergo (redacted) did not identify or evaluate Listeria monocytogenes as a known or reasonably foreseeable hazard. Raw meat pet food and its ingredients such as raw poultry, raw fruits and vegetables, and raw milk are known to be a source of Listeria monocytogenes.
2. The firm’s hazard analysis for products that undergo (redacted) did not identify or evaluate microbiological hazards from raw goat milk. According to their (redacted) formula, manufactured on Aug. 8, 2019, the recipe contains “Goats Milk,” which is listed as raw goat milk on the product labeling. Raw milk is known to be a source of a wide range of microbiological hazards (such as Escherichia coli (E. coli), Listeria, and Campylobacter).

The firm’s Sept. 13, 2019, response indicates their food safety plan will be reviewed and acknowledges potential bacteriological risks. However, their response does not include a revised hazard analysis; therefore, the FDA is unable to assess their corrective action. The FDA will verify the adequacy of their corrective actions during a future inspection.

2. The firm’s hazard evaluation did not include an evaluation of environmental pathogens whenever an animal food is exposed to the environment prior to packaging and the packaged animal food does not receive a treatment or otherwise include a control measure that would significantly minimize the pathogen.

Meat used in their raw, ready-to-eat products, in chunks or after the grinding step, is exposed to the environment at multiple steps e.g., during (redacted), during movement in open (redacted) carts, during grinding, during staging before the final product is bagged and sealed. As a specific example, during the inspection, open (redacted) carts containing raw meat in the grinder/mixer room were observed close to the walls, and the raw meat was touching the wall and a hose hanging on the wall. Environmental FDA sample INV1117248, collected during the investigation, yielded isolates of Listeria monocytogenes in six different locations throughout their facility, including the grinder/mixer room. The firm’s packaged food does not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. However, neither of their hazard evaluations evaluated environmental pathogens.

Their response dated Sept. 13, 2019, outlines the corrective actions they plan to take in response to their failure to identify and evaluate all known and reasonably foreseeable hazards for the animal food manufactured by their facility. Their corrective actions included a review of their food safety plan by their microbiologist and a third-party Preventive Controls Qualified Individual (PCQI). However, the firm has not provided their revised food safety plan. Therefore, the FDA is unable to assess their promised corrective actions, as they do not have sufficient information. The FDA will verify the adequacy of their corrective actions during a future inspection.

3. The firm failed to validate that the preventive controls identified and implemented are adequate to control the hazard.

Validation means obtaining and evaluating scientific and technical evidence that their control measure, or combination of control measures, or their food safety plan as a whole, when properly implemented, is capable of effectively controlling identified hazards, specifically, Listeria monocytogenes, E. coli O157:H7, and Salmonella.

1. In the document “FSMA FDA Products Preventative Controls Program” for frozen pet food, code 190827, dated Aug. 26, 2019, the firm identifies (redacted) of materials in chubs or sealed packages as a process control for “BIOLOGICAL Vegetative Salmonella, Listeria, and E. coli growth and toxin production in (redacted) treated ingredients.” However, their firm does not have adequate validation for their (redacted) parameters. Specifically, the firm’s method for determining the sample size and the use of standard plate count as an indicator of log reduction, instead of inoculation with pathogens or an adequate indicator organism, are inadequate.
2. In their document “FSMA FDA Products Preventative Controls Program” for frozen pet food, code 190826, dated Aug. 26, 2019, the firm identifies (redacted) as a process control for E. coli, Salmonella, and Listeria for pet food products that do not undergo (redacted). The study presented by their firm in support of this process control is (redacted). (Redacted) is also known as (redacted). This study pertains to food contact surfaces and was not designed to validate, nor is it adequate to validate, the antimicrobial efficacy of their process of (redacted).

The firm also provided what appears to be an unpublished study entitled, “(redacted).” This study uses (redacted) cubes of beef that are (redacted) for (redacted) minutes. This differs from their process, which includes (redacted) ground meat as it enters the (redacted).

The firm’s Sept. 13, 2019, response states they will conduct new validation studies for (redacted) that will include statistically valid sample sizes and inoculation of known quantities of various pathogens to substantiate a (redacted) reduction. Further, an email received from the firm on Nov. 20, 2019, states that they have scientific evidence showing (redacted) reduction kill rates for the (redacted) and will conduct a validation study to prove the log reduction under manufacturing conditions at their plant. The FDA will assess the adequacy and implementation of their validation study during their next inspection.

4. The firm failed to identify and implement preventive controls to provide assurances that any hazards requiring preventive control will be significantly minimized or prevented. Preventive controls include controls at critical control points and at other points that are appropriate for animal food safety.

The firm’s document “FSMA FDA Products Preventative Controls Program” for frozen pet food, code 190826, dated Aug. 26, 2019, identified a (redacted) as a preventive control for certain biological hazards. However, biological hazards may be reintroduced during further manufacturing e.g., mixing, (redacted) or when the animal food is exposed to their manufacturing environment after the (redacted). As noted above, environmental sampling found pathogens in their facility. Without a food safety plan that controls biological hazards at all critical control points and other points appropriate for animal food safety in their manufacturing process, their preventive controls are insufficient to ensure the biological hazards are significantly minimized or prevented.

In their Sept. 13, 2019, response, they stated their firm will include the (redacted) of all raw meat and poultry as a preventive control for the bacterial hazards. Additionally, their e-mail dated Nov. 20, 2019, stated that they started working on the validation and implementation of (redacted) for all raw frozen diet products. While the FDA acknowledges this corrective action, their response did not provide a revised food safety plan with changes in their manufacturing process and did not include adequate documentation for the FDA to fully evaluate their responses. The FDA will verify the adequacy of their corrective actions during a future inspection.

Undesirable Microorganisms in Pet Food and Their Processing Environment
The firm manufactures pet food and many of the circumstances described above are ways in which the pet food they manufacture could become contaminated by undesirable microorganisms for which they have inadequate control. Undesirable microorganisms include microorganisms that are pathogens, that subject animal food to decomposition, that indicate that animal food is contaminated with filth, or that otherwise may cause animal food to be adulterated.

On Aug. 27, 2019, FDA collected a sample of (redacted) Beef Recipe lot (redacted) sample 1117252, that was manufactured on Aug. 26, 2019. FDA laboratory analysis of this sample identified the presence of non-O157 Shiga Toxin-producing E. coli O88:H25. FDA conducted whole genome sequencing (WGS) analysis on the E. coli O88:H25 found in their pet food product. As discussed with them on Oct. 18, 2019, the results revealed several virulence markers in the genome suggesting it is pathogenic.

During the FDA inspection, the FDA also performed swabbing for the presence of environmental pathogens. Sample number INV 1117248 consisted of 100 subsamples of environmental swabs (18) and sponges (82). The FDA laboratory recovered Listeria monocytogenes from 7 of 37 subsamples analyzed for this pathogen. FDA conducted WGS analysis of the L. monocytogenes strains found in environmental sample number 1117248. As discussed with them on Oct. 18, 2019, the WGS analysis found that the L. monocytogenes strain in subsamples 23, 30, and 31, from the cart wheel, drain near mixer, and drain near grinder, respectively, of the environmental sample is related to a strain found in (redacted) in 2016. (redacted).

On (redacted), the Minnesota Department of Agriculture (MDA) collected a sample of (redacted)”, identified as “(redacted). The sample (MDA Sample Number # (redacted)) was analyzed by the MDA Microbiology Laboratory and tested positive for Salmonella Dublin. We discussed the MDA test results and FDA’s WGS analysis results with them on Nov. 6, 2019, and Feb. 27, 2020, respectively.

The presence of undesirable microorganisms in their finished product and processing environment is further evidence of the significance of their violations of the animal food hazard analysis and risk-based preventive control requirements and demonstrates that their practices are not adequate to prevent or mitigate biological hazards.