FDA 483 - Laboratorio Reig Jofre S.A. - June 14, 2019

An FDA inspection of Laboratorio Reig Jofre S.A., a sterile drug manufacturer in Toledo, Spain, revealed significant deficiencies across its production, quality control, and laboratory systems. Observations included inadequate procedures to prevent microbial contamination, failures in quality unit responsibilities and CAPA management, and insufficient laboratory controls for product release. These issues indicate a lack of robust controls essential for ensuring the quality and sterility of drug products.