The US Food and Drug Administration (FDA) has put Mid America Pet Food LLC (Mid America) on notice that the company has not adequately responded to a long list of violations documented during inspections carried out in late 2023 and early 2024.
In a Warning Letter, issued on November 22, 2024 (posted December 10, 2024 on the agency website), the FDA gave Mid America fifteen working days to notify the FDA in writing of the specific steps taken to correct any violations, including “…an explanation of each step being taken to prevent the recurrence of violations.”
A brief history
On September 3, 2023, Mid America recalled a single lot of Victor Super Premium Dog Food, Hi-Pro Plus after the South Carolina Department of Agriculture found Salmonella in a random sample. According to the company’s recall announcement, there were no reports of human or pet illness associated with the recalled product.
On October 30, 2023, the company recalled three lots of Victor Super Premium Dog Food, Select Beef Meal & Brown Rice Formula after an unnamed third party conducted random tests and found Salmonella in the product. Once again, the company reported that there were no cases of human or pet illness associated with the recalled batches.
On November 9, 2023, Mid America expanded its recall to include all products manufactured in its Mount Pleasant, Texas production facility with Best By Dates before 10/31/24. This time, the company acknowledged reports of seven human illnesses.
Also on November 9, 2023, the FDA and the CDC released reports of seven cases of Salmonella Kiambu infections “…potentially associated with pet food made by Mid America Pet Food.” Outbreak cases were reported in Alabama, California, Florida, Hawaii, Kentucky, Minnesota, and Oklahoma.
According to the CDC, illnesses started on dates ranging from January 14, 2023, to August 19, 2023. Six of the seven victims were less than one year old. One person was hospitalized.
Whole genome sequencing of the Salmonella found by the South Carolina Department of Agriculture in September 2023 showed that the strain was closely related genetically to the Salmonella recovered from outbreak victims.
The FDA inspects—twice
As part of its investigation into the Salmonella outbreak, the FDA conducted an in-depth inspection of Mid America’s Mount Pleasant production plant that began on November 2, 2023, and was completed on December 18, 2023.
The agency conducted a second inspection from January 23, 2024, through February 9, 2024, in response to a consumer complaint.
The Warning Letter issued on November 22, 2024 consolidates the findings from both inspections, and details the FDA’s dissatisfaction with the company’s response to outstanding issues raised during the inspections.
Salmonella findings
The FDA found Salmonella in 40 of 100 environmental swabs taken November 2, 2023. Seventeen of the positive swabs were from extrusion or post-extrusion areas (ie., AFTER the final cooking step).
FDA found Salmonella in three environmental swabs taken January 25, 2024 from the extrusion and post-extrusion areas. These were genetically related to seven of the positive swabs collected November 2, 2023.
The company’s own testing of finished product lots collected between December 20, 2023, and January 29, 2024, were positive for Salmonella. Ten of these lots were manufactured AFTER the company had conducted an intensive cleaning and sanitation operation.
Sanitation issues
Mid America failed to adequately implement its sanitation control program:
- treated surfaces were not allowed to remain wet for long enough to ensure effectiveness of sanitation
- multiple instances of inadequate or missing documentation of sanitation activities
- FDA observed visible debris on food-contact equipment surfaces after cleaning and sanitizing was performed
- persistence of Salmonella in production enviroment was evidence of sanitation deficiencies
Maintenance issues
- On January 23, 2024, rainwater was leaking through the roof of the facility while multiple lots of dog food were being manufactured.
- Standing water and absorbent pads were present in the staging, production, and finished product areas, including the dryer room and packaging areas
Food safety plan not followed
- Process control for chicken fat was not documented from January 13 through February 4, 2024, as specified in the company’s Food Safety Plan
- Treatment step designed to reduce Salmonella in chicken fat was not appropriately calculated in accordance with the validation study provided by the company to the FDA.
- Mid America did not conduct (or did not document) any root cause analysis to determine which preventive controls may have failed when finished product tested positive for Salmonella.
- Mid America failed to collect the required minimum number of swabs before and after sanitation to assess the impact of a Salmonella-positive test result.
What next?
The FDA will return to Mid America’s Mount Pleasant facility to conduct yet another follow-up inspection. While doing so, the agency will determine whether the company has adequately addressed all of the outstanding issues listed in the Warning Letter.
Interested in learning more about the history of pet food and its links to human and animal illness?
“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 