FDA 483 - Fermion Oy - March 17, 2023

Fermion Oy, an API manufacturer in Hanko, Finland, was inspected from March 13-17, 2023. The inspection revealed a significant failure to thoroughly review unexplained discrepancies, specifically regarding variable yields during manufacturing and out-of-specification stability results for distributed batches. The firm did not conduct adequate investigations to identify all potential root causes for these issues.