FDA 483 - Barbara Ann Karmanos Cancer Hospital - September 19, 2025

An FDA inspection of Barbara Ann Karmanos Cancer Hospital, a PET drug manufacturer in Detroit, MI, revealed significant deficiencies in production and process controls, quality assurance procedures, and sterility testing practices. The firm failed to prevent microbial contamination, adequately investigate excursions, and ensure proper aseptic manipulation, indicating a high risk of product contamination and compromised drug quality. Issues also included undocumented endotoxin investigations and prolonged sterility sample holding times.