FDA 483 - Janssen Ortho LLC - February 22, 2013

Janssen Ortho L.L.C. in Gurabo, PR, was cited for significant deficiencies in its quality systems during an FDA inspection. The firm failed to timely report serious adverse drug experiences and field alert reports for its Xarelto product, and did not thoroughly investigate over 790 consumer complaints regarding lack of drug effect. Additionally, the inspection revealed inadequate cleaning and maintenance procedures for manufacturing equipment, leading to potential contamination.