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

The FDA inspection of Agilent Technologies, Inc., conducted from July 14-17, 2025, identified significant deficiencies in the company's procedures for corrective and preventive action (CAPA). A primary concern involved CAPA 1633, initiated for mislabeled EnVision FLEX kits with incorrect expiration dates that had already been distributed to customers. The company's documentation failed to adequately justify the decision for no immediate correction based on risk, and critically, did not document a subsequent recall notification (Field Action #FAS000000174) as a correction or containment action, despite the affected product already having expired on the market. Furthermore, CAPA 1514, which addressed overdue annual reports for two diagnostic products (HercepTest and HER2 IQFISH pharmDx) since 2021, incorrectly categorized a planned action to prevent recurrence as a "preventive action" instead of a "corrective action." These observations highlight a breakdown in critical quality system processes. Under the Federal Food, Drug, and Cosmetic Act, firms are responsible for robust quality systems. Agilent Technologies, Inc. must address these issues by revising and rigorously implementing its CAPA procedures. This includes ensuring all quality problems, risk assessments, and corrective/preventive actions, such as product containment and recalls, are comprehensively documented and managed. The company must also ensure accurate categorization of actions and timely submission of all required regulatory reports to maintain compliance.