# FDA 483 - Kedrion S.p.A. - Unknown Date

Source: https://www.keypedia.com/records/483/kedrion-spa/452713da-7ba8-48f8-8efa-ec30d24851b5

> FDA 483 for Kedrion S.p.A. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kedrion S.p.A.
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: Kedrion SpA, a drug substance manufacturer in Barga, Lucca, Italy, was inspected by the FDA from April 1-7, 2025. The inspection revealed two significant observations related to quality system deficiencies. Specifically, the firm failed to consistently evaluate divergences from procedures as deviation events, leading to a lack of investigation into potential product quality impacts, and also demonstrated inconsistent adherence to written production and process control procedures.

## Related Officers

- [Erin C. Hill](https://www.keypedia.com/people/erin-c-hill/74bd0551-2319-46da-933f-5e38469699b6)
- [Lisa Phan](https://www.keypedia.com/people/lisa-phan/503a80cf-8d23-4a23-9892-2c2d9b76eb02)
- [issuing_officer](https://www.keypedia.com/people/malgorzata-g-norton/ba7b8827-0976-4abd-8abb-95d4222d2bdc)

Company: https://www.keypedia.com/companies/kedrion-spa/b2c74d2f-120b-4e20-a1cf-43d03fef31f3

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4