FDA 483 - Schmid & Son Packaging Inc - December 16, 2025

An FDA inspection of Schmid & Son Packaging Inc, a drug repackager and relabeler in Cottage Grove, MN, revealed significant deficiencies in environmental controls. The firm failed to provide adequate equipment for monitoring and controlling temperature and humidity in areas where drug products are packaged and stored. This included unqualified temperature monitoring equipment, a lack of alarm systems for temperature excursions, and no humidity control system.