# FDA 483 - Rafa Laboratories Ltd. - November 13, 2017

Source: https://www.globalkeysolutions.net/records/483/rafa-laboratories-ltd/1df3f138-9138-4f45-8508-b19e806da37f

> FDA 483 for Rafa Laboratories Ltd. on November 13, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rafa Laboratories Ltd.
- Inspection Date: 2017-11-13
- Product Type: drugs
- Office Name: FDA District Office — Silver Springs, Maryland
- Summary: Rafa Laboratories Ltd. in Jerusalem, Israel, a drug manufacturer, was cited with six observations during an FDA inspection from November 5-13, 2017. The inspection revealed significant deficiencies in aseptic processing, quality control unit responsibilities, test method validation, equipment cleaning procedures, deviation handling, and production/process control documentation. These issues indicate a lack of adherence to established procedures and controls necessary to ensure drug product quality and sterility.

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## Related Officers

- [Wendy G. Tan](https://www.globalkeysolutions.net/people/wendy-g-tan/aad9c7d5-1a63-43b6-bc25-531b7f4475a9)
- [Jose Hernandez-Guzman](https://www.globalkeysolutions.net/people/jose-hernandez-guzman/5e522aa9-a613-408f-b360-74c0fe4d8b30)

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

Office: https://www.globalkeysolutions.net/offices/fda-district-office-silver-springs-maryland/079bb75c-3759-4baa-baed-4159edd64552