FDA 483 - Renaissance Lakewood, LLC - June 06, 2023

An FDA inspection of Renaissance Lakewood, LLC in Lakewood, NJ, revealed significant deficiencies across multiple systems. Observations included poorly maintained stability chambers, inadequate documentation for stability sample handling, unjustified deviations in production processes, and unaddressed equipment leaks linked to microbial contamination. These issues indicate a lack of robust quality control and proper equipment maintenance.