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Bioiberica, SAU, a Spanish active pharmaceutical ingredient (API) manufacturer, was cited for significant current good manufacturing practice (CGMP) violations that resulted in adulterated drugs. The FDA found that the company failed to establish adequate written procedures and controls for monitoring processing steps, specifically identifying that approximately 23 batches of API were reworked in 2020-2021 due to microbiological failures and elevated residual solvent content without proper process validation or real-time monitoring systems. The rework operations lacked supporting studies to demonstrate effectiveness, and the equipment used was not equipped with adequate controls or performance summaries to ensure consistent drug quality.