FDA 483 - Higley Industries, Inc. - September 12, 2025

Higley Industries, Inc. in Dyersville, IA, a human drug manufacturer, was cited for significant deficiencies across its quality control, production, and record-keeping systems. Repeat observations highlight failures in raw material identity testing, inadequate quality unit oversight, and insufficient investigation of discrepancies. The inspection revealed a systemic lack of adherence to cGMP requirements, impacting product quality and control.