483
OMRIX Biopharmaceuticals LtdFDA 483 - OMRIX Biopharmaceuticals Ltd - March 05, 2020
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Record Details
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.
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ID · 48acf8c5-42fe-4931-8f4e-0671dbda7c6f