483
GenIbet Biopharmaceuticals, S.A.FDA 483 - GenIbet Biopharmaceuticals, S.A. - January 21, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
GenIbet Biopharmaceuticals, S.A. in Oeiras, Lisbon, Portugal, a biological drug product manufacturer, was inspected by the FDA. The inspection revealed deficiencies in complaint handling procedures, specifically the failure to maintain written records for drug product complaints. Additionally, the firm lacked established written procedures for annual evaluations and reviews of all investigations conducted for drug products, particularly for VOWST®.
Open in Dashboard
ID · bae8b4d8-e80c-4f74-b3f3-60143f53510b