FDA 483 - Bolger & O'Hearn Inc - December 19, 2023
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · ac3f365b-3b10-4d99-b018-c0e5c08838d8