Medina Baking and Powder Products, Inc. Warning Letter Details

Summary

Medina Baking and Powder Products, Inc. manufactured food products including liquid flavors, marshmallow powder, and ice cream stabilizer but failed to comply with Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls regulations under 21 CFR part 117. During an August-September 2021 inspection, the FDA identified serious violations of CGMP & PC requirements and found that several products with revised labels—including Medina brand Vanilla Flavor Imitation (White), Artificial Flavor Mantecado, and Marsh-Mallow No. 2 Meringue—remained misbranded due to inadequate allergen and color declarations. Although the company revised some labels during the inspection and submitted corrective actions in September 2021, the FDA determined these efforts were insufficient to address the ongoing misbranding and manufacturing control violations.