FDA 483 - Sofie Co. - January 22, 2024

An FDA inspection of Sofie Co., dba Sofie in Sanford, FL, a PET drug facility, identified significant deficiencies across three observations. These included inadequate production and process controls, such as poor aseptic techniques and cleaning practices. The firm also lacked adequately trained personnel, failing to identify and address Out-of-Specification trends, and its facilities were found to be inadequate in preventing contamination, with instances of mold and yeast linked to construction and HVAC issues.