FDA 483 - Kedrion Biopharma Inc.

An FDA inspection of Kedrion BioPharma, Inc. in Melville, NY, a biologic manufacturer, revealed significant deficiencies in their production of RhoGAM. The firm failed to follow written production and process control procedures, inadequately investigated deviations, lacked established procedures for microbiological contamination control, and did not exercise appropriate data integrity controls over computer systems used for PPQ lots.