N-Molecular Inc. d.b.a. SOFIE – FDA 483, May 16, 2019

N-Molecular Inc. d.b.a. SOFIE in Haverhill, MA, a sterile PET drug manufacturer, was cited for significant deficiencies during an FDA inspection from May 8-16, 2019. The firm failed to follow written quality assurance procedures, including change control for critical GMP systems and product impact assessments for temperature excursions. Additionally, essential equipment, specifically an incubator used for sterility testing, was found unsuitable for its intended purpose due to temperature control issues and ice formation, with no backup available.