# FDA 483 - Fermion Oy - Unknown Date

Source: https://www.keypedia.com/records/483/fermion-oy/e9359956-71c2-4266-8e7f-c1ef3c6b675a

> FDA 483 for Fermion Oy on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fermion Oy
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Fermion Oy, Espoo Plant, a contract testing laboratory, revealed significant data integrity issues related to LC-MS equipment, including the ability to delete data without audit trail capture, unreviewed electronic data, and inadequate data backup. The inspection also cited a lack of change control for work instructions and an ineffective CAPA for previously identified data integrity problems. These findings indicate serious deficiencies in the firm's quality management system.

## Related Officers

- [Drug National Expert](https://www.keypedia.com/people/sandra-a-boyd/c469103a-0917-407a-b9d1-98273358dfeb)

Company: https://www.keypedia.com/companies/fermion-oy/8f4a5a6d-60c9-4ee0-a73f-d9107516d746

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