SOFIE Co. dba SOFIE – FDA EIR, Feb 5, 2019

An FDA surveillance inspection of SOFIE Co. dba SOFIE, a Positron Emission Tomography (PET) drug manufacturer in Gilroy, CA, was conducted from January 31 to February 5, 2019. The inspection, carried out under regulatory framework 21 CFR 212 (cGMP for PET drugs) and Compliance Program CPGM 7356.002P, identified four significant deficiencies, documented on Form FDA 483.

Key issues included the failure to ensure proper review and approval of executed batch records before drug product release and distribution. The firm also demonstrated deficiencies in maintaining adequate cleaning records and practices for critical aseptic processing environments (ISO 5 Laminar Air Flow Hood and ISO 5 Hot Cell), which could compromise contamination prevention. Furthermore, the inspection found that aseptic processing simulations (media fills) were inadequate, not accurately reflecting routine operational conditions or worst-case scenarios, thereby impacting personnel qualification. Finally, laboratory test records lacked complete documentation for critical in-process tests performed by technicians.

Facility Manager, Mr. Hai M. Vu, acknowledged the observations and committed to addressing these issues in a written response to the FDA within 15 business days. The firm manufactures PET drug products for distribution in California, and no product recalls have occurred since the previous inspection in 2016.