483
Rafa Laboratories Ltd.FDA 483 - Rafa Laboratories Ltd.
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Record Details
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.
- Company
- Rafa Laboratories Ltd.
- Product Type
- Drugs
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ID · 8462743a-9e9c-4525-b8df-8f81aa2b9533