FDA 483 - Janssen - Cilag Spa. - January 25, 2019

An FDA inspection conducted at Janssen Cilag via C. Janssen snc in Latina, Italy, from January 21-25, 2019, identified two critical observations documented in a Form FDA 483. These findings pertain to the firm's laboratory controls and data integrity, essential for maintaining pharmaceutical product quality under Good Manufacturing Practices. The first observation noted that laboratory controls did not consistently ensure accurate and reliable test results. Specifically, for certain batches of (b)(4) Tablets, a degradation peak detected during Ultra Performance Liquid Chromatography (UPLC) analysis, utilizing Empower-3 software, was not properly integrated, evaluated, or reported. Subsequent recalculations performed during the inspection revealed degradation levels exceeding the established reporting limits, indicating a failure in accurately assessing product stability. The second observation highlighted that the Empower chromatographic system software did not appropriately report product quality characteristics. The procedures for data processing within Empower lacked crucial, specified integration parameters—such as inhibition integration times and baseline settings—for various tests including assay and content uniformity across multiple product batches. This omission could potentially hinder the detection of known or unknown components, thereby compromising the comprehensive evaluation of product quality. Janssen Cilag is required to thoroughly address these observations by developing and implementing robust corrective and preventive actions. A detailed response must be submitted to the FDA, demonstrating the firm's commitment to rectify these deficiencies and ensure the accuracy, reliability, and compliance of its quality control processes.