FDA 483 - SOFIE Co. dba SOFIE - February 05, 2019

An FDA inspection of SOFIE Co. dba SOFIE, a PET drug manufacturer in Gilroy, CA, revealed significant deficiencies in quality assurance procedures, facility contamination control, personnel training, and laboratory record-keeping. The firm failed to ensure proper batch release authorization, maintain adequate cleaning records for critical equipment, provide representative aseptic processing training, and accurately document laboratory test performers.