Carolina Liquid Chemistries Corp – FDA 483, Feb 17, 2026

An FDA inspection of Carolina Liquid Chemistries Corp in Brea, CA, a manufacturer, repackager, and relabeler, revealed significant deficiencies in their quality management system. Observations included inadequate risk management documentation, specifically incomplete FMEAs for reagent product lines, and a misrepresentation of residual risks. The firm also failed to establish adequate procedures for timely complaint handling, lacking guidance for identifying product defects and conducting complete Medical Device Reporting (MDR) assessments. Furthermore, the company did not adequately verify purchased finished bulk products, such as Gamma-Glutamyl Transferase (GGT), against specified requirements before repackaging and relabeling.