Renaissance Lakewood, LLC – FDA 483, Jul 29, 2026

An FDA inspection of Renaissance Lakewood, LLC, a drug manufacturer in Lakewood, NJ, revealed significant deficiencies in their production and process controls. The firm failed to establish adequate written procedures, specifically concerning the visualization of unidirectional airflow during aseptic filling operations and the validation of a visual inspection method. These issues indicate a lack of robust quality assurance practices that could impact drug product identity, strength, purity, and quality.