483
Fermion OyFermion Oy – FDA 483, Mar 17, 2023
Record Details
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.
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