FDA 483 - Bioiberica, SAU - September 20, 2024

An FDA inspection conducted from September 13-20, 2024, at Bioiberica, SAU's drug substance manufacturing facility in Palafolls, Barcelona, Spain, revealed significant deficiencies in quality control and laboratory procedures. The inspection found that the Quality Unit lacked proper oversight of unplanned maintenance, with over 2500 work orders processed by the Engineering department from 2022-2024 without adequate assessment of their potential impact on product batches. Furthermore, investigators observed inadequate equipment cleaning practices, noting substantial material residue in production equipment between batches, which were merely labeled "empty and ready for use." Instances of cleaning cloths left in equipment and foreign bodies were also documented. The company’s products exhibited quality control issues, including numerous Out-of-Specification (OOS) results for microbiology and potency (e.g., 20 microbiology OOS in 2024), without a thorough investigation into repeat deviations. Finally, laboratory controls were found to be deficient, specifically that the endotoxin release test used for a key active pharmaceutical ingredient lacked complete validation regarding its sensitivity, reproducibility, spike recovery, and the potential interference from residual solvents. These observations indicate a need for Bioiberica, SAU to implement robust corrective and preventive actions to ensure compliance with good manufacturing practices and safeguard product quality and safety.