FDA 483 - KEDRION S. p. A.
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KEDRION S. p. A. in Bolognana, Italy, a bio-pharmaceutical drug manufacturer, was cited for significant deficiencies during an FDA inspection. The firm failed to adequately investigate and correct issues from a previous inspection, particularly concerning manufacturing process controls for Kedbumin drug product aggregates and filaments. Additionally, the inspection revealed inadequate space, issues with sample representativeness, and uncorrected observations related to extractables/leachables and toxicology studies.
- Company
- KEDRION S. p. A.
- Product Type
- Biologics
ID · d7e4943c-6b90-440c-8261-9ac0312903aa