FDA 483 - I3 PHARMACEUTICALS LLC - February 22, 2022

An FDA inspection of I3 PHARMACEUTICALS LLC in Warminster, PA, from February 7-22, 2022, revealed significant deficiencies in manufacturing and quality control. Observations included inadequate cleaning procedures and validation, insufficient environmental controls for temperature and humidity, and failures in quality assurance oversight. The firm also lacked thorough investigations into out-of-specification results and proper laboratory control mechanisms.