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

The FDA conducted an inspection of Laboratorio Reig Jofre S.A., a sterile drug product manufacturer in Toledo, Spain, from June 15 to June 23, 2023. The inspection identified numerous significant deviations from Current Good Manufacturing Practices (CGMP), as documented in a Form FDA 483. Major violations centered on a deficient Quality Control (QC) unit, where analysts underreported visible particles due to inadequate procedures and lack of timely retraining. The firm's complaint investigations for visible particulates were superficial, often failing to characterize foreign matter, perform risk assessments, or investigate API suppliers even after external lab findings implicated raw materials. Critical issues were also found in preventing microbiological contamination, including absent closure integrity verification for sterile APIs and an inadequate environmental monitoring program that failed to detect microbial contamination. Data integrity was severely compromised by the disposal of original GMP documents and raw test data, poor document control, missing analytical records, and significant delays in logging deviations, leading to production without essential environmental monitoring. Furthermore, laboratory test methods for bacterial endotoxins and sterility lacked adequate controls and re-verification, and the employee training program was insufficient, failing to ensure the reliability of personnel in critical testing and manufacturing roles. Laboratorio Reig Jofre S.A. must implement robust corrective and preventive actions to address these systemic failures to ensure compliance with regulatory standards and the quality and safety of its sterile drug products.