FDA 483 - GenIbet Biopharmaceuticals, S.A.

An FDA inspection of Genibet Biopharmaceuticals SA in Oeiras, Portugal, identified significant deficiencies across multiple areas of their drug manufacturing operations. The firm lacks adequate written procedures and supporting data for production and process controls, raising concerns about product quality and purity. Additionally, critical issues were noted with equipment cleaning processes and decontamination procedures, indicating a risk of cross-contamination.