FDA EIR - Sunshine Mills, Inc. - March 31, 2022

This FDA Consumer Complaint Report, dated March 31, 2022, details an incident involving Sunshine Mills, Inc., the manufacturer of Evolve Simply Six Limited Ingredient Recipe Turkey & Brown Rice Recipe dog food. On October 25, 2021, a consumer reported that their large dog experienced extreme lethargy, slowed breathing, and mobility issues after consuming the dog food for three days, noting a strong plastic odor. The adverse health effects began on October 22, 2021, improving only after the food was discontinued, though the dog's health was not fully restored by November 9, 2021. The FDA's initial evaluation on November 22, 2021, acknowledged the reported off-odor and adverse reaction. While retain samples of the specific product lot (TE124) were tested and found to have no irregularities, the complaint was referred to a compliance officer. This action was taken in anticipation of a scheduled inspection for Sunshine Mills, Inc., in Fiscal Year 2022. This referral is particularly significant given that a previous FDA inspection completed on September 3, 2021, had already resulted in an "Official Action Indicated" status for the manufacturer, suggesting ongoing regulatory scrutiny. The report does not detail specific new violations found directly from this complaint, but rather indicates continued FDA surveillance.