FDA 483 - Janssen Ortho LLC - May 29, 2015

Janssen Ortho L.L.C. in Gurabo, PR, a drug manufacturer, was inspected and cited for significant deficiencies in its quality control and sampling procedures. Observations included inadequate documentation and in-process controls for packaging, leading to inaccurate product counts, and non-representative sampling plans for both drug products and incoming raw materials. These issues indicate a systemic failure to ensure product quality and compliance with manufacturing specifications.