FDA 483 - SOFIE Co. dba SOFIE - April 21, 2022

SOFIE Co. dba SOFIE, a PET drug manufacturer in Morgantown, WV, was cited for failing to implement adequate procedures to ensure equipment suitability for its intended purposes. The inspection revealed deficiencies including a lack of light intensity verification for drug product inspection and the absence of written preventive maintenance programs for manufacturing equipment and aseptic manipulation units, which could adversely affect drug quality.