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

Agilent Technologies, Inc. in Carpinteria, CA, received a Form FDA 483 for inadequate corrective and preventive action (CAPA) procedures. The firm failed to properly document risk-based decisions for product corrections, did not adequately document field actions related to mislabeled kits with incorrect expiration dates, and miscategorized actions for unsubmitted PMA annual reports. These deficiencies indicate a systemic issue in managing quality problems and ensuring regulatory compliance.