FDA 483 - Janssen Pharmaceuticals, Inc. - January 24, 2025

Janssen Pharmaceuticals Inc. in Athens, GA, an Active Pharmaceutical Ingredient (API) manufacturer, was cited for an inadequate raw material receipt sampling method during an FDA inspection. The firm failed to ensure representative sampling of drummed raw materials, lacked documented evidence for sampled containers, and had a sampling procedure that did not specify amounts or locations for sampling. This deficiency affected the manufacture of several API lots, including Apalutamide and Esketamine HCL.