FDA 483 - N-Molecular Inc. d.b.a. SOFIE - February 28, 2018

M-Molecular Inc. d.b.a. SOFIE in Haverhill, MA, a sterile PET drug manufacturer, received a Form 483 with six observations. The inspection revealed significant deficiencies in equipment suitability and maintenance, production and process controls for aseptic manufacturing, facility contamination prevention, and adherence to quality assurance procedures. These issues indicate a lack of robust controls to ensure product quality and sterility.