# FDA 483 - OMRIX Biopharmaceuticals Ltd - March 05, 2020

Source: https://www.keypedia.com/records/483/omrix-biopharmaceuticals-ltd/48acf8c5-42fe-4931-8f4e-0671dbda7c6f

> FDA 483 for OMRIX Biopharmaceuticals Ltd on March 05, 2020. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OMRIX Biopharmaceuticals Ltd
- Inspection Date: 2020-03-05
- Product Type: biologics
- Office Name: International Compliance Team
- Summary: 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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Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321