FDA WARNING_LETTER - Sunshine Mills Inc - December 13, 2018

On June 25, 2019, the FDA issued a Warning Letter to Sunshine Mills, Inc. following a nine-day inspection from November 14 to December 13, 2018, at their Tupelo, MS facility. The inspection was prompted by consumer complaints and a voluntary recall due to elevated vitamin D levels in dog food, leading to potential toxicity, kidney failure, and death in animals.

The FDA found violations of hazard analysis and risk-based preventive controls for animal food (21 CFR part 507, subpart C), rendering products adulterated under the FD&C Act. Specifically, the firm failed to implement adequate preventive controls for vitamin and mineral toxicity/deficiency, resulting in the use of an incorrect, higher concentration vitamin D ingredient. Their "internal programs" and "batching/mixing" controls were insufficient to prevent this.

Additionally, the firm failed to identify inadequate thiamine in extruded dry cat food as a foreseeable hazard in their hazard analysis, despite thiamine's heat instability and cats' susceptibility to deficiency, which can be fatal.

The company's proposed corrective actions, including ingredient tracking, quarterly vitamin testing, finished goods testing, and an updated hazard analysis, were noted but could not be evaluated due to a lack of supporting documentation and a defined timeframe for implementation.

Furthermore, Sunshine Mills failed to report a reportable food event to the Reportable Food Registry within 24 hours,