FDA 483 - SciVac Ltd - March 27, 2023

An FDA inspection of SciVac LTD, a sterile drug manufacturer in Rehovot, Israel, revealed significant deficiencies across multiple areas. Observations included inadequate procedures to prevent microbiological contamination, insufficient employee training, failures in recording and justifying deviations, and a quality control unit that did not fully follow its own written procedures. These issues collectively indicate a serious lack of control over sterile drug manufacturing processes.