FDA 483 - Bioiberica, SAU - February 04, 2022

An FDA inspection of Bioiberica, S.A.U's drug substance manufacturing facility in Palafolls, Barcelona, revealed significant deficiencies across multiple areas. The firm was cited for inadequate cleaning validation, uncontrolled reprocessing procedures, and a quality control unit that failed to ensure data integrity and proper test method verification. Additionally, the inspection found a lack of a written stability testing program and insufficient investigation follow-up for unexplained discrepancies.