FDA 483 - Higley Industries, Inc. - September 21, 2023

An FDA inspection of Higley Industries Inc in Dyersville, IA, a contract manufacturer of hand sanitizer, revealed significant deficiencies across multiple areas of its quality system. The firm lacked adequate controls for production records, raw material testing, laboratory operations, equipment maintenance, and quality unit oversight. These issues indicate a systemic failure to adhere to current Good Manufacturing Practices for drug products.