FDA 483 - Laboratorio Genove SA - September 09, 2022

Laboratorio Genove SL, an OTC drug manufacturer in Bigues I Riells, Barcelona, Spain, was cited with six observations during an FDA inspection. The inspection revealed significant deficiencies in quality control, data integrity, stability testing, laboratory controls, facility and equipment design, and process validation, indicating a lack of robust cGMP systems. These issues collectively suggest a systemic failure to ensure the identity, strength, purity, and quality of drug products.