FDA 483 - SOFIE Co. dba SOFIE - August 07, 2025

SOFIE Co. dba SOFIE in Gilroy, CA, a PET drug manufacturer, was inspected and received a Form 483 with three observations. The inspection revealed significant deficiencies in equipment cleaning and sanitization procedures, inadequate batch release processes lacking verification of pre-production cleaning and electronic data review, and issues with personnel training record management. These findings indicate a moderate level of non-compliance with GMP regulations.