FDA 483 - Kedrion Biopharma Inc. - March 27, 2024

Kedrion Biopharma, Inc. in Melville, NY, was inspected from March 20-27, 2024, and received a Form 483 with two observations. The inspection revealed issues with ineffective cleaning procedures for critical manufacturing equipment, leading to multiple temperature excursions in the fractionation department. Additionally, the firm failed to document deviations from batch production and control records, with numerous temperature excursions identified only after batch completion.