FDA 483 - Laboratorios Liconsa SAU - January 17, 2025

An FDA inspection of Laboratorios Liconsa's bioanalytical facility in Azuqueca de Henares, Guadalajara, Spain, identified significant deficiencies in method validation and documentation practices. The firm failed to adequately determine the stability of stock solutions, include all tested analytical sequences in reports, and maintain complete documentation for method validation experiments. These issues indicate a lack of robust quality control and record-keeping for critical analytical processes.