483
Higley Industries, Inc.Higley Industries, Inc. – FDA 483, Sep 12, 2025
Record Details
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.
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