FDA 483 - SOHM Inc. - November 05, 2024

SOHM, Inc. in Carlsbad, CA, was inspected regarding its manufacturing of OTC drug products, Salicylic Acid 2% and Hydroquinone USP 4%. The inspection revealed significant deficiencies across its quality system, including inadequate production and process controls, a non-existent quality control unit, and poor equipment and labeling management. These issues indicate a severe lack of adherence to cGMP regulations, potentially impacting drug product quality, safety, and purity.