Patheon Manufacturing Services LLC – FDA 483, Aug 7, 2026

An FDA inspection of Patheon Manufacturing Services LLC in Greenville, NC, revealed critical deficiencies in its sterile drug product manufacturing operations. The firm exhibited inadequate quality unit control over GMP documents, failed to establish robust production and process controls, and demonstrated significant lapses in aseptic processing, environmental monitoring, and visual inspection programs. These issues collectively indicate a high risk to the quality and sterility assurance of manufactured drug products.