FDA 483 - Janssen Ortho LLC - June 08, 2009

An FDA inspection of Janssen Ortho LLC in Gurabo, PR, from May 26 to June 8, 2009, revealed significant deficiencies in quality control unit procedures and manufacturing batch records. The firm failed to provide documented evidence for validation sample collection and lacked accurate documentation for in-process controls and manufacturing deviations for Carisbamate Tablets. These issues indicate a lack of adherence to established protocols and proper record-keeping practices.