FDA 483 - iuvo BioScience Operations, LLC - May 27, 2021

An FDA inspection of iuvo BioScience Operations, LLC, a non-clinical laboratory in Rush, NY, identified a significant issue regarding the facility's archival practices. The firm failed to provide adequate space with limited access for the storage and retrieval of raw data and specimens from completed studies. This observation highlights concerns with data integrity and the secure management of critical study materials.