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

An FDA inspection of N-Molecular Inc. d.b.a. SOFIE's Haverhill, MA facility occurred from February 12 to 28, 2018, revealing multiple deficiencies in adherence to current Good Manufacturing Practices (cGMP) for PET drug manufacturing. The inspection concluded with a six-item FDA Form 483, highlighting critical issues. Main violations included the absence of adequate procedures for ensuring equipment suitability and cleanliness, with the latter being a repeat observation from a prior inspection. The facility's physical infrastructure was deemed inadequate, featuring cracked floors, dirty surfaces, and a damaged shipping door, which presented contamination risks. Additionally, the company lacked sufficient production and process controls to ensure consistent PET drug quality, identity, strength, and purity. The firm also failed to consistently follow written quality assurance procedures, specifically regarding the timely review and approval of investigations and environmental monitoring. Finally, proper procedures for equipment maintenance were not implemented. SOFIE management acknowledged the findings, committing to a written response to the FDA within 15 business days and pledging to voluntarily correct the identified issues with appropriate resources to achieve compliance.