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

N-Molecular Inc. d.b.a. SOFIE, a radiopharmaceutical manufacturer located in Haverhill, MA, was inspected by the FDA from May 8-16, 2019. This follow-up inspection aimed to assess the firm's adherence to Current Good Manufacturing Practices (cGMP) and its response to a previous inspection in February 2018, which had resulted in significant deficiencies and a subsequent Warning Letter. The primary violations noted during the current inspection, detailed in a two-item FDA Form 483, included a failure to follow written quality assurance procedures, particularly concerning the evaluation of temperature excursions for critical equipment. Additionally, equipment used for testing, specifically an incubator vital for sterility and environmental monitoring sample incubation, was found unsuitable for its intended purpose due to temperature control issues and ice formation. These issues directly compromise the reliability of critical test results for sterile positron emission tomography (PET) imaging agents. The company was cooperative, and management committed to providing a written response to the FDA regarding the new observations. The firm had already completed most corrective actions from the previous Warning Letter, with six commitments still in progress. Key ongoing actions include the implementation of an electronic Quality Management System by November 2019 to improve oversight, the acquisition and validation of new incubation equipment, and addressing verbal observations related to facility maintenance, vendor qualification, and label control.