FDA 483 - Agilent Technologies, Inc. - July 17, 2025

Agilent Technologies, Inc. in Carpinteria, CA, was cited for significant deficiencies in its corrective and preventive action (CAPA) procedures during an FDA inspection from July 14-17, 2025. The firm failed to adequately establish procedures for risk-based decision making, proper documentation of containment actions for mislabeled products with incorrect expiration dates, and correct classification of actions related to unsubmitted PMA annual reports. These issues indicate a breakdown in the firm's quality management system.