FDA 483 - Fagron, Inc - November 18, 2021

Fagron, Inc., a manufacturer and repackager of active pharmaceutical ingredients in Saint Paul, MN, was cited with ten significant observations during an FDA inspection from 11/1/2021 to 11/18/2021. The firm demonstrated widespread deficiencies across its quality system, laboratory controls, facilities, equipment, and material handling, including repeat observations from previous inspections. Key issues involved inadequate supplier control, failure to conduct thorough investigations, lack of written procedures, absence of stability data, and poor laboratory data integrity and cross-contamination prevention.