483
Renaissance Lakewood, LLCRenaissance Lakewood, LLC – FDA 483, Jun 6, 2023
Record Details
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.
View Company Profile
ID · a205d385-4bcf-413f-bf08-4e99a0204006
Other documents for Renaissance Lakewood, LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.