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3D Imaging Drug Design and Development LLC received a warning letter for significant Current Good Manufacturing Practice (CGMP) violations in the production of positron emission tomography (PET) drugs, specifically Fludeoxyglucose F18, making the products adulterated under federal law. During a June 2025 inspection, the FDA identified failures in facility adequacy and equipment cleanliness procedures that could compromise product quality and prevent contamination. Additionally, the company failed to properly update its drug listing for Fludeoxyglucose F18 in the FDA's electronic Drug Registration and Listing System (eDRLS) as required by regulation.