FDA 483 - SOFIE Co. dba SOFIE - August 28, 2025

SOFIE Co. dba SOFIE, a PET Drug Manufacturer in Morgantown, WV, was cited for failing to implement adequate procedures for equipment maintenance. Specifically, the firm did not follow manufacturer recommendations for replacing critical components of High-Performance Liquid Chromatograph (HPLC) systems used for radiochemical identity and purity testing of PET drug products. This deficiency could adversely affect the quality and validity of test results for their manufactured drugs.