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

An FDA inspection of N-Molecular Inc. d.b.a. SOFIE, a radiopharmaceutical manufacturer located in Haverhill, MA, was conducted from November 6 to November 20, 2024. The inspection, which evaluated adherence to Good Manufacturing Practices (GMP) for Positron Emission Tomography (PET) drugs, identified three main deficiencies documented on a Form FDA-483. The primary issues included incomplete batch production records, specifically lacking testing results. Additionally, the company failed to consistently follow its written quality assurance procedures. This was evidenced by inadequate disinfection of critical surfaces after contact by personnel, recurring failures in sterility test negative controls attributed to insufficient material disinfection, and an operator performing aseptic operations without full qualification approval. Furthermore, equipment critical to PET drug production was not adequately maintained to prevent potential alteration of drug quality, a violation referenced under 21 CFR 212.30(c). Examples cited were chipped paint on an electrical outlet within an ISO-5 aseptic area and a cleaning extender tool with fraying and dirty tape. In response to these findings, N-Molecular Inc. d.b.a. SOFIE acknowledged the observations and committed to providing a written response within the stipulated 15-business day timeframe. During the inspection, the firm took immediate action to replace the deficient electrical outlet and ordered a new cleaning tool. They also initiated a deviation record for the operator qualification issue. This inspection highlights the importance of rigorous adherence to quality control and equipment maintenance in pharmaceutical manufacturing.