FDA 483 - SciVac Ltd - March 27, 2023

SciVac LTD, a sterile drug manufacturer in Rehovot, Israel, was cited for significant deficiencies in its aseptic processing controls, personnel training, deviation management, and quality control unit procedures. The inspection revealed issues including inadequate sporicidal agent use, flawed environmental and personnel monitoring, insufficient training for visual inspection, unrecorded deviations, and poor documentation reconciliation practices. These findings indicate a high severity of non-compliance impacting the sterility assurance and overall quality system.