FDA 483 - GenIbet Biopharmaceuticals, S.A. - January 21, 2025

From January 13 to January 21, 2025, the U.S. Food and Drug Administration (FDA) inspected the manufacturing facility of GenIbet Biopharmaceuticals, S.A. in Oeiras, Portugal. The inspection focused on the production of biological drug products, specifically the fecal microbiota product VOWST. The FDA investigators identified two significant areas of concern regarding the company's quality management systems. First, the firm failed to maintain a proper system for recording and investigating complaints. Specifically, when an external laboratory notified the firm of failed test results or discrepancies, GenIbet did not log these events as formal complaints or non-conformances. In some instances, the company performed undocumented investigations or conducted unauthorized tests outside of the approved manufacturing records. Second, the facility’s procedures for annual quality reviews were inadequate. The company’s policy only required a review of investigations deemed 'significant,' which led to the exclusion of approximately 400 investigations from the annual report, preventing a thorough assessment of product consistency. These observations were documented under the Federal Food, Drug, and Cosmetic Act. GenIbet Biopharmaceuticals is required to respond to these findings by detailing their planned corrective actions or submitting objections to the FDA to ensure the facility meets necessary safety and quality standards.