FDA 483 - Bolger & O'Hearn Inc - December 19, 2023

An FDA inspection of Bolger & O'Hearn Inc in Fall River, MA, a human drug manufacturer, revealed nine significant observations related to their hand sanitizer drug product. Deficiencies included failures in analytical testing, product formulation, quality control criteria adherence, equipment cleaning, and proper storage of active pharmaceutical ingredients. The firm also lacked adequate written procedures for quality unit functions, stability testing, component identity verification, and proper record-keeping for labeling.