FDA 483 - N-Molecular Inc. d.b.a. SOFIE - November 20, 2024

An FDA inspection of N-Molecular Inc. d.b.a. SOFIE, a sterile PET drug producer located in Haverhill, MA, was conducted from November 6 to November 20, 2024. The inspection identified several critical observations indicating potential deviations from Good Manufacturing Practices. Major issues included incomplete batch production records, specifically the absence of original test results and calculations for critical release parameters like sterilizing filter integrity, leading to undocumented data conversions. The firm also demonstrated a failure to consistently follow written quality assurance procedures. This was evidenced by inadequate disinfection of materials transferred into critical aseptic processing areas (ISO-5 cleanrooms), which was linked to multiple instances of microbial contamination in sterility tests. Furthermore, an operator performed aseptic manufacturing of PET drug products for an extended period without a reviewed and approved media fill qualification, compromising sterility assurance. Lastly, the inspection noted poor maintenance of equipment within aseptic areas, such as chipped paint on an electrical outlet in a laminar flow hood and a damaged, unclean extender tool used for cleaning a dispensing hot cell. To address these observations, N-Molecular Inc. is expected to implement comprehensive corrective and preventive actions to ensure compliance with regulatory standards for sterile drug production.