USDA-inspected facility fails two FDA pet food inspections

Lewis Sausage Co., Inc. (Lewis), a meat and poultry processor that also manufactures raw pet food under contract, failed two FDA inspections during an eleven-month period.

The company manufactures a range of raw dog food and raw cat food products on behalf of Viva Raw, LLC.

Viva Raw does not carry out any manufacturing at its location of record. The company’s address of record, as listed by the North Carolina Secretary of State, belongs to a single-family home in a residential area of Durham, North Carolina.

At the completion of a June 2023 inspection of Lewis’ operations, FDA investigators reported that the company “…did not take adequate measures to significantly minimize or prevent the growth of undesirable microorganisms in [its] animal food,” according to information contained in the FDA Form 483 Inspectional Observations obtained in response to a Freedom of Information Act request.

Lewis was reinspected in May 2024. In the FDA Form 483 issued upon completion of inspection, investigators highlighted several areas of concern, including:

validation studies did not confirm that the process used to reduce or control pathogens was sufficiently effective to eliminate Salmonella, E. coli, or Listeria monocytogenes from the finished products
monitoring for pathogens during production was not carried out according to the written monitoring procedure
environmental monitoring was not carried out with adequate frequency, given the size, scope, and production volume
finished product sampling program for Salmonella, E. coli, and Listeria monocytogenes was inadequate
hazard analysis document did not include nutrient toxicity or nutrient deficiency as hazards likely to occur, even though some of the finished products carry the statement, “Complete and Balanced” on the product label.

The fall-out

On December 26, 2023, the FDA received a consumer complaint alerting the agency to the death of a dog that had been fed Viva For Dogs brand Chunked Duck (Product code 17BVD02).

The affected dog vomited the entire day, experienced seizure-like activity and was taken to a veterinary emergency facility. The dog was found to have severe thrombocytopenia (low platelet counts) and did not survive.

A second dog in the same household, ate a much smaller quantity of the product, vomited just once, and recovered.

The FDA received a second consumer complaint on January 31, 2024. The consumer reported that their cats had developed gastrointestinal illness (vomiting) after being fed Viva Raw brand Pure Rabbit Raw Cat Food. The cats recovered when their diet was switched to a Viva Raw chicken product.

The FDA took no immediate action on this complaint, indicating that it would be raised at the next establishment inspection.

On January 23, 2024, after receiving notification the FDA had found both Salmonella and Listeria monocytogenes in a sample of the product, the company initiated a recall of four products that contained the duck meat used the implicated production lot of the Chunked Duck.

The recall, which was communicated to consignees by email rather than via a public recall notice, including the following four products bearing lot number 22853:

VIVA for dogs Chunked duck
VIVA for cats duck
VIVA for dogs GROUND duck
VIVA PURE duck PETFOODMIXER

During the May 2024 inspection at Lewis Sausage, the FDA collected finished product for testing, and found Listeria monocytogenes in a sample.

On June 12, 2024, Lewis Sausage initiated a recall of five products carrying the same lot code (Lot #21244) in which the FDA had found the pathogen.

On July 1, 2024, Viva Raw issued a press release announcing a recall of the five products, which included:

VIVA for cats turkey (1 lb (454g); Lot #21244)
VIVA for dogs CHUNKED turkey (1 lb (454g); Lot #21244)
VIVA for dogs GROUND turkey (1 lb (454g); Lot #21244)
VIVA for puppies beef & turkey GROUND (1 lb (454g); Lot #21244)
VIVA PURE turkey for cats & dogs (1 lb (454g); Lot #21244)

The take-aways

A pet food company’s claim that its products have been manufactured using “human-grade” ingredients or in a USDA-inspected facility is no guarantee that the products are safe.
Viva Raw LLC is just one of many smaller pet food suppliers that do not manufacture their own products. They rely on third-party manufacturers to produce their formulas.
Not all product recalls are announced via a news release on the FDA’s website. Many recalls—whether of pet foods or people foods—are only made public through the FDA’s Enforcement Reports.

Reporting a pet food problem

The FDA relies heavily on reports from pet owners and veterinarians to alert them to safety issues with pet foods. Especially useful are reports that include veterinary information and details on the suspect food (brand, variety, batch codes, et cetera).

The following links will help you to make your report to the FDA. Just click anywhere on the blue to be taken directly to the appropriate FDA web page.

How to Report a Pet Food Complaint. Read this web page before beginning to file your complaint. It provides a list of the information you should try to have at hand before you begin to file. If you are missing some information, do not despair. Even partial information will be helpful.

Consumer Complaint Coordinators. This FDA page supplies the telephone number for the agency’s Consumer Complaint Coordinator in each state. Use this approach if you wish to make your complaint by telephone. If you do not reach a live voice, please leave a detailed message so that the coordinator can return your call.

Safety Reporting Portal. Use this FDA page if you prefer to file your report on-line with the agency. Begin by clicking on the button “Report as Guest” and continue by answering each question as it is presented to you.

“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

Available from all major on-line retailers, including:

FDA releases report on Purina complaints investigation

Between November 22, 2023, and April 15, 2024, the US Food and Drug Administration (FDA) received approximately 1,300 adverse event reports for a variety of Purina pet foods.

Today (July 31, 2024) after more than half a year of follow-up work, including pet owner interviews, lab analyses, and a plant inspection, the agency released the results of its investigation.

Initial triage of complaints

Following an initial review of the ~1300 Adverse Event Reports (ie., complaints), agency veterinarians established a set of criteria to select complaints for more detailed follow-up. The criteria were:

Owner’s willingness to be contacted for additional information
Type of symptoms reported (primarily gastrointestinal, hepatic and neurologic cases were selected)
Time between the illness and submission of report (prioritizing recent illness)
Availability of veterinary medical records
Availability of product with lot number and best-by date

Out of the 1300 complaints received, 107 met all of the established criteria.

The follow-up

The FDA pursued one or more of the following avenues for each of the 107 complaints flagged for follow-up.

Review of veterinary medical records
Interview of pet owners about their pets’ medical and diet histories and other potential exposures
Lab testing of pet food samples still in the pet owners’ possession, including tests for
- Mycotoxins (aflatoxin, fumonisin, deoxynivalenol)
- Excess vitamin D
- Bacteria (including Salmonella, E. coli, Listeria, Staphylococcus aureus)
- Pesticides
- Phosphine (a fumigant used to control insects on grain and other commodities)
- Rancid fat
- Metals

In addition to tests carried out on samples obtained from pet owners, FDA collected 20 sealed product samples from retail settings, representing four brands of Purina pet food. These samples were subjected to the same battery of tests as listed above.

Finally, the FDA conducted a comprehensive Preventive Controls Surveillance Inspection at the Purina manufacturing facility in Clinton, Iowa, the manufacturing site of the most frequently mentioned products in the complaints.

The lab findings

Lab tests did not reveal the presence of mycotoxins, pesticides, phosphine, rancid fat, excess vitamin D, pathogenic bacteria, or excessive heavy metals in any of the samples obtained from pet owners or from retail settings.

Bacillus cereus was found in 17 samples obtained from open packages of pet food collected from pet owners’ homes. Bacillus cereus is a common environmental contaminant, and genetic analysis of the 17 strains showed that they were unrelated to each other. None of the sealed packages of pet food contained Bacillus cereus.

Lab tests were conducted for the following metals and micronutrients: arsenic, cadmium, calcium, chromium, cobalt, copper, iron, lead, magnesium, manganese, mercury, molybdenum, phosphorus, potassium, selenium, sodium, sulfur, thallium and zinc. Findings for metals, including micronutrients, were not of clinical concern, meaning levels were likely too low to trigger animal illness in otherwise healthy pets, according to the FDA report.

The inspection

A team consisting of two FDA investigators and one inspector from the Iowa Department of Agriculture conducted a three-day inspection that began on April 30, 2024.

During the course of the inspection, the team reviewed the firm’s food safety plan, hazard analysis, GMPs, employee training, complaints, pest control, management interviews, and associated records.

The visit did not include a physical inspection of the production plant. No environmental, in-process, or finished product samples were collected during the inspection.

At the end of the inspection, the FDA issued a Form 483, citing the company for not conducting a reanalysis of its food safety plan after having been notified by a representative of the FDA regarding complaints associated with a new potential hazard in pet food.

The plant manager claimed to have been unaware of the complaints/new potential hazard in the pet food they were manufacturing. He explained that complaints were handled at the corporate level. The corporate Director of Quality Assurance acknowledged having been made aware of the complaints. He stated that they had been working on the potential issue at the corporate level with their microbiologists and currently did not see it as a hazard.

The FDA’s conclusion (quoted verbatim)

After thoroughly analyzing pet food adverse event reports, testing opened products from pet owners and sealed products from retail settings, and conducting a facility inspection, the FDA has determined the existing evidence does not identify a public health concern that could explain the symptoms detailed in these adverse event reports about Purina pet foods.

The agency followed standard processes in evaluating the adverse event reports and identifying those most likely to yield additional information. However, this situation did present unique challenges in that there was a large volume of reports describing a wide array of reported symptoms, but relatively few met the criteria for follow up. The agency is aware of various media outlets and bloggers that have reported a high number of adverse events. Unfortunately, the FDA did not receive data to fully evaluate or substantiate most of these cases. As a science-based regulatory and public health agency, the FDA relies on data to be able to analyze adverse events and identify causes of illness.

Throughout its analysis, the FDA had a conscious commitment to notify the public if it uncovered information, such as laboratory results indicating contamination or a specific illness in pets that ate a particular lot, that could translate into actionable advice for veterinarians or pet owners. The agency has previously issued safety advisories in situations when there was a common link between the reports, such as findings of a pathogen, vitamin overdose, or disease agent that connected the food to the illnesses. In the recent situation regarding the adverse event reports mentioning Purina pet food, there was no direct or consistent connection between the wide range of adverse events submitted to the FDA, and evidence does not conclusively link the reported adverse events to Purina pet food.

The FDA continues to monitor and evaluate pet food adverse event reports to identify potential follow-up actions. The agency encourages consumers and veterinarians to submit reports about issues with pet food electronically through the Safety Reporting Portal or by calling an FDA Consumer Complaint Coordinator. For additional support with using the online Safety Reporting Portal, the FDA now offers the SmartHub – Safety Intake Portal, where an electronic assistant helps walk individuals through the process of submitting their report. For an explanation of the information and level of detail that would be helpful to include in a report to the FDA, please see How to Report a Pet Food Complaint.

“An invaluable resource for busy pet owners” – Food Safety News

Available from all major on-line retailers, including:

Recalls and Alerts: July 16–17, 2024

Here is today’s list of food safety recalls, product withdrawals, allergy alerts and miscellaneous compliance issues. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

If you would like to receive automatic email alerts for all new articles posted on eFoodAlert, please submit your request using the sidebar link.

“An invaluable resource for busy pet owners” – Food Safety News

Available from all major on-line retailers, including:

Outbreak/Illness Investigations

USA (Updates): FDA continues to investigate outbreaks of Salmonella Irumu and Salmonella Typhimurium, neither of which has yet been linked to an identified product. The Salmonella Irumu outbreak has grown to 29 cases, and the Salmonella Typhimurium outbreak now stands at 87 cases. Traceback investigations have been initiated for both outbreaks.

United States

Food Safety Recall: Wiers Farm Inc. recalls Whole Cucumbers (1.5-2.5 inch diameter, 6-9 inch length; Pack date June 5, 2024) and Wiers Farm bagged Salad Cucumber (2 lb; June 5, 2024 and June 6, 2024) due to Listeria monocytogenes contamination.

Food Safety Recall: AW Farms, LLC recalls approximately 6,900 pounds of hot dog products that were produced without the benefit of federal inspection. Please refer to the recall notice for a complete list of affected products.

FDA Warning Letter: FDA warns Discover Fresh Foods, LLC that a December 11, 2023, through January 22, 2024 inspection of the company’s manufacturing facility for refrigerated ready-to-eat (RTE) dips and spreads revealed the presence of Listeria monocytogenes , a human pathogen, in the production facility and serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.

Canada

Pet Food Safety Recall: Vitakraft Sun Seed, Inc. recalls various Sunseed “Vita Prima” and Vitakraft “Vita Smart” hedgehog pet foods due to possible Salmonella contamination. Please refer to the recall notice for a complete list of affected products.

United Kingdom and Ireland

Food Safety Recall (UK): Johnston Mooney & O’Brien recalls various baked products (Best before 21 July 2024) due to foreign matter contamination (pieces of metal). Please refer to the recall notice for a complete list of affected products.

Hong Kong and Singapore

Food Safety Recall (Hong Kong): LIU MA KEE LIMITED recalls bottled preserved bean curd (255g; Best before August 7, 2025) due to excessive Bacillus cereus contamination.