PETNET SOLUTIONS, INC. – FDA 483, Feb 15, 2023

An FDA inspection of PETNET SOLUTIONS, INC. in Broken Arrow, OK, a PET drug manufacturer, revealed significant deficiencies in equipment construction and maintenance, cleaning procedures, and batch production records. The firm failed to ensure equipment surfaces were non-reactive, implement adequate cleaning validation, and properly document major equipment used in batch production. These issues indicate a lack of control over critical manufacturing processes for PET drugs.