FDA EIR - SOFIE Co - August 11, 2023

An FDA inspection of SOFIE Co's Totowa, NJ facility, conducted from July 19 to August 11, 2023, under the Positron Emission Tomography compliance program, revealed significant deficiencies. The inspection covered quality, facilities and equipment, materials, production, laboratory control, and packaging and labeling systems. Investigators issued a 4-item FDA-483, highlighting critical issues. Firstly, facility conditions were deemed inadequate to prevent product contamination, citing 119 instances of microbial recoveries, including objectionable organisms, in ISO 5 manufacturing areas over two years without effective corrective actions. Physical observations also included visible residues, corrosion, and cracks in critical sterile processing equipment. Secondly, labeling and packaging operations lacked sufficient controls, evidenced by a product mix-up complaint. Thirdly, the company's complaint procedures were deficient in adequately investigating the root cause of failures. Finally, the firm failed to properly document when a PET drug product did not meet specifications. SOFIE management acknowledged these findings, committing to address all observations and provide a written response to the Agency within 15 business days. Immediate actions for facility deficiencies were initiated during the inspection.