FDA 483 - SOFIE Co - August 11, 2023

SOFIE Co, a PET drug manufacturer in Totowa, NJ, was cited for significant quality control deficiencies during an FDA inspection. Observations included persistent microbial contamination in ISO 5 sterile manufacturing areas with inadequate corrective actions, and visible residues and corrosion in critical equipment. The firm also failed to adequately control labeling and packaging operations, leading to product mix-ups, and demonstrated deficiencies in complaint handling and out-of-specification investigations, including releasing an OOS batch for patient use.