FDA 483 - Janssen Ortho LLC - August 28, 2018

Janssen Ortho LLC in Gurabo, PR, received a Form 483 for significant deficiencies in laboratory controls, manufacturing process monitoring, and investigation practices. The inspection revealed issues with chromatographic data integrity, failure to identify root causes for dissolution rate variability in Invokana tablets, and the release of Invokamet lots with unresolved dissolution failures. These observations indicate a lack of robust quality control and investigation procedures impacting drug product quality and assurance.