FDA 483 - Sofie Co. - September 22, 2021

Sofie Co., dba Sofie, a PET Drug Manufacturer in Sanford, FL, was inspected and received two observations. The inspection revealed significant and repeated issues with facility contamination control, including persistent mold and bacterial recoveries in cleanrooms, inadequate mold remediation, and inconsistent cleaning procedures. Additionally, the firm failed to follow written laboratory procedures for endotoxin testing, leading to unassessed retests and concerns about data reliability.