FDA 483 - Laboratorios Liconsa SAU - January 17, 2025

An FDA inspection of Laboratorios Liconsa, a bioanalytical facility in Azuqueca de Henares, Spain, revealed significant deficiencies in method validation and documentation practices. The observations primarily concern inadequate stability determinations for stock solutions, incomplete reporting of analytical sequences, and insufficient documentation to reconstruct method validation experiments. These issues indicate a lack of robust quality control in their analytical processes.