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

N-Molecular Inc. d.b.a. SOFIE in Haverhill, MA, a sterile PET drug producer, received a Form 483 with three observations. The inspection revealed significant issues including inadequate record-keeping for critical release tests, failure to follow quality assurance procedures for aseptic processing and material disinfection, and poor maintenance of equipment in critical production areas. These deficiencies indicate a high potential for product contamination and impact on drug quality.