FDA 483 - Indiana Botanic Gardens, Inc - September 30, 2025

Indiana Botanic Gardens, Inc. in Hobart, IN, an OTC drug manufacturer, was cited with two observations during an FDA inspection. The inspection revealed deficiencies in following written production and process control procedures, specifically concerning inconsistent mixing times for an OTC product without proper validation. Additionally, the firm failed to store drug products under appropriate conditions, leading to inadequate segregation of expired and cosmetic products from those undergoing stability testing.