FDA 483 - Catalent Maryland Inc

An FDA inspection of Paragon Gene Therapy/Catalent Maryland Inc., a biologics/cell therapy manufacturer in Harmans, Maryland, revealed significant deficiencies across multiple areas. The firm failed to consistently follow standard operating procedures, exhibited inadequate deviation management and trending, and lacked sufficient controls to prevent material mix-ups. Additionally, issues were noted with preventing recurrence of cell culture vessel defects and establishing expiration dates for manufacturing media.