Janssen Pharmaceuticals Inc. – FDA 483, Nov 1, 2024

An FDA inspection conducted at Janssen Biopharmaceuticals, Inc., Raritan, NJ, from October 28 to November 1, 2024, resulted in the issuance of a Form FDA 483. This document outlines observations of objectionable conditions and practices related to the company's lentiviral vector manufacturing operations. The inspection revealed two primary issues. Firstly, the control and maintenance of critical manufacturing systems on the lentiviral manufacturing line were found to be deficient. A total of 68 events impacting these systems occurred between 2022 and 2024, with more than 30 of these incidents happening within the last twelve months. Secondly, the firm failed to initiate investigations (nonconformance reports) in a timely manner following the detection of deviations. Company procedures require these reports to be created within a specified timeframe, but since January 2024, 19 nonconformance reports exceeded this deadline. Notably, at least three of these reports were delayed by 21 days or more, signifying a lapse in the firm's quality system responsiveness. These observations, issued under Section 704(b) of the Federal Food, Drug and Cosmetic Act, highlight potential deviations from Current Good Manufacturing Practices. Janssen Biopharmaceuticals is required to evaluate these findings and provide a comprehensive response detailing its planned or implemented corrective and preventive actions to address the identified deficiencies.