FDA 483 - Janssen Ortho LLC - March 28, 2023

Janssen Ortho LLC in Gurabo, PR, was cited with three observations during an FDA inspection from March 13-28, 2023. The firm demonstrated deficiencies in quality control, including inadequate justification for reduced raw material testing leading to technically unavoidable particles in Apalutamide tablets, and a failure to thoroughly review out-of-specification and out-of-trend laboratory results for products like Xarelto and Canagliflozin. Additionally, the inspection revealed that equipment surfaces in the packaging process generated foreign material, specifically loose white filaments, altering the purity of Xarelto tablets.