FDA 483 - SciVac Ltd - March 27, 2023

An FDA inspection conducted on March 27, 2023, at an unnamed pharmaceutical firm, revealed significant deficiencies outlined in an FDA 483 document. The primary issues revolved around inadequate procedures to prevent microbiological contamination in sterile drug manufacturing. Observations included the lack of routine use of sporicidal agents in Grade A filling environments, despite numerous recoveries of spore-forming microbes. Environmental and personnel monitoring plans were found to lack scientific support, with deficiencies in sampling locations, timing, and operator testing protocols for aseptic interventions. Inadequate cleaning of critical aseptic areas was also noted. Furthermore, employees lacked sufficient training for their assigned functions, particularly concerning the scientific justification for defect categories and the establishment of defect kits. Deviations from production and process control procedures were not consistently recorded or justified, highlighted by delayed deviation openings and the absence of required investigations for visual inspection and gowning failures. Lastly, the quality control unit's responsibilities and procedures were not fully followed, with issues in reconciling qualification documentation and inadequate retain inspection protocols. These observations indicate non-compliance with the Federal Food, Drug, and Cosmetic Act, requiring the firm to implement comprehensive corrective actions to address the identified objectionable conditions and practices.