PETNET Solutions, Inc. – FDA 483, Mar 2, 2026

During an inspection from February 24 to March 2, 2026, PETNET Solutions, Inc. in Atlanta, GA, a manufacturer of Positron Emission Tomography (PET) drugs, was cited for significant deficiencies. Observations included a lack of adequate procedures for equipment cleaning, maintenance, and environmental monitoring within Hot Cells, as well as inadequate production and process controls, specifically concerning aseptic techniques during PET drug preparation and dispensing. These issues indicate a failure to ensure the quality and purity of PET drugs.