FDA 483 - OMRIX Biopharmaceuticals Ltd - March 05, 2020

Omrix Biopharmaceuticals Ltd. in Nes-Ziona, Israel, was inspected by the FDA from February 25 to March 5, 2020, and received four observations. The inspection revealed deficiencies primarily in laboratory controls, record-keeping practices, and batch production records, indicating a need for improved adherence to quality standards for drug product manufacturing.