FDA 483 - Sofie Co dba Sofie - July 25, 2025

An FDA inspection of Sofie Co dba Sofie, a PET Drug Manufacturer in Sterling, VA, revealed a critical failure in quality control. The firm did not conduct appropriate laboratory determinations to ensure PET drug products met specifications before release. This included inadequate investigations into out-of-specification bacterial endotoxin results, unauthorized retesting, and the release of affected batches without proper confirmatory testing.