FDA 483 - Sofie Co. - September 03, 2025

During an FDA inspection conducted from September 1 to September 3, 2025, SOFIE Co. dba SOFIE, a PET Drug Manufacturer in Kansas City, MO, received a Form FDA 483 for significant observations. The primary issue noted was the firm's lack of adequate production and process controls to ensure the consistent production of sterile PET drugs that meet required standards of identity, strength, quality, and purity. Specifically, an operator was observed inserting their head into an ISO classified area during cleaning, exposing unprotected parts of their face. This presents a critical contamination risk for sterile drug products, as the ISO area is used for manufacturing them. The inspection found that the company's existing gowning and cleaning procedures were not adequate or fully followed, as goggles were only specified for certain cleaning steps, not for the full duration of direct exposure within the critical sterile environment. The FDA 483 report is issued under Section 704(b) of the Federal Food, Drug, and Cosmetic Act, which mandates reporting conditions indicating potential product contamination or adulteration. SOFIE Co. is required to address these observations by implementing comprehensive corrective and preventive actions to ensure compliance and prevent risks to product sterility and patient safety.