FDA 483 - Decatur Memorial Hospital - PET Production - January 15, 2026

Sofie Co. dba SOFIE, a PET Drug Manufacturer in Decatur, IL, was cited for significant deficiencies in its quality system. The inspection revealed failures to adequately investigate out-of-specification results and deviations, leading to ineffective corrective and preventive actions. Additionally, the firm lacked sufficient controls over production and laboratory data acquisition systems, compromising data integrity and record retention.