FDA 483 - Kedrion S.p.A.

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.