Higley Industries, Inc.September 12, 2025

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

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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.

Company: Higley Industries, Inc.
Inspection Date: September 12, 2025
Product Type: Drugs
Office: Kansas City District Office
Person: Monica E. Murie

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ID · b777659a-5afd-48af-9c8d-9a1731e33a25