Fermion OyMarch 17, 2023

FDA 483 - Fermion Oy - March 17, 2023

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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.

Company: Fermion Oy
Inspection Date: March 17, 2023
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
People: Freddy Ortiz Colon
Lisa Shin (Investigator)
David A. Oluwo (Pharmacy Intern/Certified Pharmacy Technician)

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ID · a0b28fa2-b9b7-4dd0-9175-8f204d9e1b6b