FDA 483 - SOFIE Co. dba SOFIE - October 28, 2025

The FDA conducted an inspection of SOFIE Co. dba SOFIE, a PET Manufacturer in Houston, TX, from October 22-28, 2025. This inspection revealed significant issues indicating non-compliance with good manufacturing practices, as outlined under the Federal Food, Drug, and Cosmetic Act.

Key violations included an inadequate cleanroom design, specifically the lack of a designated sterile gowning area, which poses a risk of product contamination. The firm also exhibited insufficient production and process controls to prevent contamination during PET drug manufacturing, with written procedures failing to adequately define necessary safeguards. A major concern was the recurring failure to properly investigate and implement effective corrective actions for multiple environmental monitoring out-of-specification results. These incidents involved repeated recoveries of mold, fungi, and bacteria in critical cleanroom areas, with investigations often found to be inadequate in identifying root causes or preventing recurrence. Additionally, personnel were observed to lack the necessary training and experience for their assigned aseptic tasks, demonstrating poor sterile gloving techniques, neglecting proper disinfection protocols, and failing to follow established procedures for fallen components.

To address these observations, SOFIE Co. must implement comprehensive corrective and preventive actions to ensure facility design prevents contamination, strengthen production controls, conduct thorough investigations into deviations, and ensure personnel are adequately trained to maintain product quality and safety.