FDA 483 - Laboratorio Reig Jofre S.A. - June 23, 2023

Laboratorio Reig Jofre S.A. in Toledo, Spain, a sterile drug product manufacturer, was cited for significant deficiencies across its quality control, complaint investigation, and sterile manufacturing processes. Observations included inadequate visible particle testing, deficient complaint investigations for particulate matter, and a lack of established procedures to prevent microbiological contamination. The firm also failed to maintain complete laboratory records, ensure accurate test methods, and provide adequate employee training.