FDA EIR - SOFIE Co - August 11, 2023

The FDA conducted an unannounced inspection of SOFIE Co, located at 60 Commerce Way, Totowa, NJ, from July 19 to August 11, 2023. This inspection was part of a compliance program focused on Positron Emission Tomography (PET) drug products. The previous inspection in 2017 found no deficiencies. However, the recent inspection revealed several issues, resulting in a 4-item FDA-483 being issued.

Key violations included inadequate facilities that could lead to contamination, uncontrolled labeling and packaging operations risking product mix-ups, insufficient complaint investigation procedures, and failure to document when a PET drug product did not meet specifications. These issues were identified across various systems, including Quality, Facilities & Equipment, Materials, Production, Laboratory Control, and Packaging & Labeling.

SOFIE Co, established in 2005, specializes in radiopharmaceuticals for PET scans. The company operates multiple locations across the U.S. and is registered with the FDA through the end of 2023. The facility manager, Ms. Garcia Simon-Clarke, received the inspectional observations and committed to addressing the deficiencies. The firm promised to provide an initial written response within 15 business days. No samples were collected during the inspection, and there were no refusals.

The inspection was conducted by FDA investigators Tamil Arasu and Rose Jean-Mary. The firm is expected to implement corrective actions to resolve the identified issues and ensure compliance with FDA regulations.