Janssen Biotech, Inc. – FDA EIR, Mar 5, 2018

An FDA Good Manufacturing Practice (GMP) inspection of Janssen Biotech, Inc.'s Malvern, PA facility took place from February 21 to March 5, 2018. The inspection, conducted under established guidelines for licensed biological therapeutic drug products and active pharmaceutical ingredient (API) processes, focused on the manufacturing of Remicade Pre-Formulated Bulk (PFB) API.

The primary observation noted on Form FDA 483 concerned incomplete written records for investigations into batch failures or components not meeting specifications. Specifically, several batches of Bovine APO Transferrin exceeded the action limits for Ethylenediaminetetraacetic Acid (EDTA). These non-conforming material batches were released and used in media production for API manufacturing without the media undergoing appropriate EDTA testing, and only a basic form was completed instead of a comprehensive lab investigation. Additionally, an investigation into a decrease in process capability for the API PFB Bioactivity Assay was found to be incomplete, lacking a thorough review and assessment of stability data.

Janssen Biotech's management acknowledged the observation and committed to implementing immediate corrective actions, along with providing a written response to the Philadelphia District Director within 15 working days.