FDA 483 - CIMBAR PERFORMANCE MINERALS, INC. - July 18, 2025

CIMBAR PERFORMANCE MINERALS, INC. in Chatsworth, GA, an API manufacturer, was inspected and received a Form 483 with two observations. The inspection revealed significant issues with process control, specifically deviations from validated manufacturing procedures that were not documented or justified. Additionally, the firm failed to thoroughly investigate unexplained discrepancies and batch failures to meet specifications, releasing non-conforming products based on inadequate justifications.