FDA 483 - OHM Pharma, Inc. - April 29, 2025

An FDA inspection of OHM Pharma, Inc. in Mineral Wells, TX, a manufacturer of non-sterile liquid OTC drug products, intermediates, and APIs, revealed significant deficiencies. The firm failed to establish adequate cleaning procedures, use appropriately designed equipment, perform process validation, and implement a stability monitoring program. These observations indicate serious concerns regarding the firm's manufacturing controls and product quality.