FDA EIR - iuvo BioScience Operations, LLC - April 15, 2022

An FDA Good Manufacturing Practices (GMP) inspection of Iuvo BioScience Operation LLC., a contract testing laboratory in Rush, NY, was conducted from April 11-15, 2022. The inspection covered drug manufacturing and medical device regulations (CP7356.002, CP7382.845) and focused on microbiological sterility testing (LMS profile class). Iuvo BioScience performs toxicology, microbiology, and chemistry analysis for drugs, devices, and biologics, and repackages biological indicator strips. The inspection identified seven significant deficiencies, documented in an FDA Form 483. Main issues included the quality control unit failing to fully follow established procedures, specifically regarding incomplete and untimely deviation and laboratory investigations that lacked proper conclusions and follow-up. The firm also failed to adhere to procedures designed to prevent microbiological contamination of sterile drug products, showed inadequate environmental controls in aseptic areas, and had deficiencies in monitoring environmental conditions, including a lack of trending data. Furthermore, there was insufficient validation for aseptic processes and cleaning, and inadequate controls over computerized systems, such as unauthorized personnel possessing privileges to delete raw analytical data and the absence of routine audit trail reviews. Management, led by President & CEO Mr. Benjamin Burton, was issued the Form 483 and committed to providing a written response addressing these observations within fifteen business days. The FDA will evaluate this response before determining any further regulatory action.