FDA 483 - 3D Imaging Drug Design and Development - June 13, 2025

3D Imaging Drug Design and Development LLC, a PET drug manufacturer in Little Rock, AR, was cited for numerous deficiencies during an FDA inspection. The observations highlight significant issues across equipment maintenance, laboratory controls, quality assurance, production processes, and material specifications, indicating a broad lack of adherence to good manufacturing practices. These findings suggest a high severity of non-compliance that could impact the identity, strength, quality, and purity of their PET drug products.