# FDA 483 - Fermion Oy - March 17, 2023

Source: https://www.globalkeysolutions.net/records/483/fermion-oy/a0b28fa2-b9b7-4dd0-9175-8f204d9e1b6b

> FDA 483 for Fermion Oy on March 17, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fermion Oy
- Inspection Date: 2023-03-17
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

## Related Officers

- [Freddy Ortiz Colon](https://www.globalkeysolutions.net/people/freddy-ortiz-colon/10993029-31ff-44ec-b5c7-75c5ed827e7b)
- [Investigator](https://www.globalkeysolutions.net/people/lisa-shin/13c87687-fe3d-41a5-8973-42be901a5b0c)
- [Pharmacy Intern/Certified Pharmacy Technician](https://www.globalkeysolutions.net/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)

Company: https://www.globalkeysolutions.net/companies/fermion-oy/b862f941-91c8-429c-9aa5-0f6f98ad802d

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1