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:
eFoodAlert 