FDA 483 - PhytogenX, Inc. - February 10, 2020

An FDA inspection of PhytogenX, Inc., a drug manufacturer in Morgantown, PA, revealed significant deficiencies across multiple areas. Observations included failures in following and documenting established laboratory control mechanisms and test procedures, inadequate investigation of unexplained discrepancies, and a lack of adherence to written quality control unit responsibilities and procedures, including several Standard Operating Procedures.