Kedrion Biopharma Inc. – FDA 483, May 21, 2026

Kedrion Biopharma Inc. in Melville, NY, a manufacturer of Source Plasma derivatives, received an FDA Form 483 with eight observations highlighting significant deficiencies. Issues included ineffective equipment cleaning, inaccurate batch records, inadequate equipment identification, and failures in laboratory control mechanisms. The inspection also found problems with inventory control, environmental monitoring alarms, trending of in-process data, and a lack of pre-approval supplement submission for a process change.