Janssen Ortho LLC – FDA 483, Jun 5, 2026

Janssen Ortho LLC in Gurabo, PR, a non-sterile drug manufacturer, received a Form 483 with six observations primarily concerning quality control and production issues. Key deficiencies include inadequate nitrosamine risk assessments, insufficient cleaning validation for nitrosamine precursors, and a lack of ongoing nitrosamine testing for US-marketed products. Additionally, the firm failed to address recurring out-of-trend dissolution results, lacked controls against unauthorized record reproduction, and had incomplete laboratory record reviews.