483
Kedrion S.p.A.Kedrion S.p.A. – FDA 483
Record Details
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.
- Company
- Kedrion S.p.A.
- Product type
- drugs
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ID · 452713da-7ba8-48f8-8efa-ec30d24851b5
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