Wellmill, LLC dba Vitamix Laboratories – FDA Warning Letter, Dec 12, 2025

Wellmill, LLC, operating as Vitamix Laboratories, received an FDA warning letter following an inspection of its Nesconset, New York, facility conducted between December 3 and December 12, 2025. The agency found that the company’s juice products were produced under conditions that could potentially harm consumer health, violating the Juice Hazard Analysis and Critical Control Point (HACCP) regulations and the Federal Food, Drug, and Cosmetic Act. The core violation involves the company’s failure to establish a proper safety plan for its probiotic juice blends. The FDA identified several unaddressed risks, including environmental contamination from harmful bacteria like Salmonella and E. coli during blending, the potential for pathogen growth due to a lack of temperature controls, and the physical hazard of glass fragments in bottled products. Additionally, the company did not apply a required treatment to ensure a significant reduction in microorganisms at its facility, which is a mandatory safety step for juice processors. Although the company responded to earlier warnings by updating labels and citing its existing sanitation protocols, the FDA deemed these responses inadequate. The agency clarified that general quality programs and supplier testing do not fulfill the legal requirement for a comprehensive, product-specific hazard analysis. Vitamix Laboratories is required to submit a written response within 15 working days outlining the specific steps taken to correct these violations and prevent their return. Continued failure to comply may result in legal consequences, including product seizures or the suspension of the facility"s registration.