FDA 483 - Janssen Biotech, Inc. - July 29, 2025

An FDA 483 document issued on July 29, 2025, to an unnamed firm by the Philadelphia District Office, details significant observations regarding its operational and quality control practices. The inspection highlights two primary areas of non-compliance under the Federal Food, Drug, and Cosmetic Act.

Firstly, deficiencies were noted in the firm s laboratory controls concerning bioburden testing. The method validation and verification procedures did not align with current compendial requirements, failing to incorporate updates or adequately evaluate previous validations. Critically, observed bactericidal effects in several test articles during bioburden method validation were not properly remediated, meaning the test method was not modified to overcome these issues, and the validation did not account for potential batch-to-batch variations, thereby compromising the assurance of drug product identity, strength, quality, and purity.

Secondly, the firm failed to conduct thorough reviews of Out-of-Specification (OOS) test results. Specifically, an investigation into a failed osmolarity test for a raw material lacked scientific soundness. The root cause identified to invalidate the initial OOS result was not justified, and no additional studies were performed to rule out laboratory errors. An acceptable retest result from a different media vial was used to invalidate the initial OOS without supporting evidence for the invalidity of the first result or for potential product variability.

These observations require the firm to propose and implement corrective actions to address the identified deficiencies and ensure compliance with regulatory standards.