FDA 483 - GenIbet Biopharmaceuticals SA

An FDA inspection of GenIbet Biopharmaceuticals SA, a drug substance/drug product manufacturer in Oeiras, Portugal, revealed significant deficiencies in production and process controls, equipment cleaning, and decontamination procedures. The firm lacked adequate written procedures and supporting data for manufacturing processes, failed to validate cleaning processes effectively, and did not adequately demonstrate decontamination to prevent cross-contamination. These issues indicate a lack of control over critical manufacturing operations.