# FDA 483 - Rafa Laboratories Ltd. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/rafa-laboratories-ltd/8462743a-9e9c-4525-b8df-8f81aa2b9533

> FDA 483 for Rafa Laboratories Ltd. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rafa Laboratories Ltd.
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Rafa Laboratories, Ltd. in Jerusalem, Israel, a sterile drug manufacturer, revealed significant deficiencies in aseptic processing controls. Observations included inadequate smoke studies, lack of visible particulate inspection, poor aseptic practices, and issues with cleaning agents, sampling procedures, and reference standard qualification.

## Related Documents

- [483 - 2017-11-13](https://www.globalkeysolutions.net/records/483/rafa-laboratories-ltd/1df3f138-9138-4f45-8508-b19e806da37f)
- [483 - 2019-11-25](https://www.globalkeysolutions.net/records/483/rafa-laboratories-ltd/59927c5c-15dd-47b0-bf99-cd4c71a0444c)

## Related Officers

- [Juandra V. Williams](https://www.globalkeysolutions.net/people/juandra-v-williams/809c7741-f0a9-4fa4-bdf2-59042eb5bd94)
- [Cameron I. Smith](https://www.globalkeysolutions.net/people/cameron-i-smith/ca9e2b5f-7286-4b4e-bbed-21d3ddd69d23)
- [Zelong Deng](https://www.globalkeysolutions.net/people/zelong-deng/cffa325f-33dc-47be-8e01-479b41f507b6)
- [sharon.thoma@fda.gov](https://www.globalkeysolutions.net/people/sharon-k-thoma/d72ee980-45a4-4f2c-9b1e-e29798492e7d)

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

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321