FDA 483 - Bioiberica, SAU - February 04, 2022
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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.
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