FDA 483 - Hill Dermaceuticals, Inc. - October 14, 2025

Hill Dermaceuticals, Inc. in Sanford, FL, was inspected and cited for significant deficiencies across its manufacturing operations and supply chain security. Observations included poorly maintained equipment and facilities posing contamination risks, inadequate calibration controls for critical instruments, and a complete lack of systems to comply with Drug Supply Chain Security Act verification requirements. These issues indicate a serious lapse in maintaining a state of control over drug product quality and traceability.