FDA 483 - Janssen Ortho LLC - February 22, 2016

Janssen Ortho LLC in Gurabo, PR, received a Form 483 with three observations related to manufacturing drug products. The inspection revealed deficiencies in the routine maintenance of automated control systems, inadequate computer system controls for record changes, and a lack of proper records and procedures for equipment maintenance and cleaning. These issues indicate a moderate level of concern regarding quality system oversight and data integrity.