FDA 483 - Janssen Ortho LLC - June 13, 2011

Janssen Ortho L.L.C. in Gurabo, PR, a drug manufacturer, was cited for deficiencies in its quality system. The firm failed to adequately investigate a product recall for Topomax due to TBA contamination, not extending the assessment to all potentially affected batches. Additionally, laboratory controls for evaluating drug products for contaminants were found to be insufficient.