FDA 483 - N-Molecular, Inc. dba SOFIE - January 13, 2020

An FDA inspection of M-Molecular, Inc. dba SOFIE, a PET drug manufacturer in Colonie, NY, revealed significant deficiencies in quality control and personnel training. Observations included a failure to verify an established analytical test procedure for Fludeoxyglucose F-18 (FDG) release testing. Additionally, the firm did not implement adequate corrective actions for recurring out-of-specification results caused by poor laboratory practices and lacked necessary GMP training records for manufacturing personnel.