FDA 483 - Stratus BioSystems, LLC - November 10, 2021

Stratus BioSystems, LLC was cited for significant deficiencies in its manufacturing of injectable products derived from human gestational tissues. The inspection revealed a lack of a quality control unit, inadequate aseptic processing validation, and insufficient environmental monitoring. Furthermore, the firm failed to investigate sterility failures, validate cleaning processes, and properly test donors for cytomegalovirus, indicating severe control and quality assurance issues.