FDA 483 - KEDRION S. p. A.

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.