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

During an inspection conducted from September 22-30, 2025, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to Indiana Botanic Gardens, Inc., an OTC drug manufacturer located in Hobart, Indiana. The inspection identified two significant observations related to the firm's compliance with Good Manufacturing Practices. The first observation cited a failure to follow written production and process control procedures, specifically regarding the manufacturing of an OTC product. The FDA noted inconsistent mixing times during production without adequate validation, raising concerns that batches may not be uniform. This violates 21 CFR 211.100(b), which requires complete manufacturing and control instructions to assure the identity, strength, quality, and purity of drug products. The second observation concerned the inappropriate storage of drug products. Investigators found inadequate segregation of materials in the stability storage area, where expired OTC drug products were stored alongside products undergoing stability testing and even a cosmetic product. This practice jeopardizes the identity, strength, quality, and purity of drug products and is contrary to 21 CFR 211.142(b). Indiana Botanic Gardens, Inc. is expected to promptly address these observations by implementing comprehensive corrective actions to ensure compliance with federal regulations and prevent recurrence.