# FDA 483 - Rafa Laboratories Ltd. - November 25, 2019

Source: https://www.globalkeysolutions.net/records/483/rafa-laboratories-ltd/59927c5c-15dd-47b0-bf99-cd4c71a0444c

> FDA 483 for Rafa Laboratories Ltd. on November 25, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rafa Laboratories Ltd.
- Inspection Date: 2019-11-25
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Rafa Laboratories Ltd. in Jerusalem, Israel, a drug product manufacturer, revealed significant deficiencies across multiple areas. Observations included incomplete batch production records, failure to establish time limits for production phases, and inadequate investigations into unexplained discrepancies. Additionally, issues were noted with equipment qualification, environmental monitoring in aseptic processing areas, and adherence to laboratory control mechanisms.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/saied-a-asbagh/215bfa90-995f-4310-baf3-cd9d37639b7b)

Company: https://www.globalkeysolutions.net/companies/rafa-laboratories-ltd/bdb90cb2-b440-40cb-bc61-d12ca7c2c836

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1