Marc S. Berridge, Ph.D.
President
3D Imaging Drug Design and Development LLC
9015 Carti Way
Little Rock , AR 72205
United StatesFEI 3009143510Issued Dec 4, 2025Center for Drug Evaluation and Research (CDER)
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3009143510.
Violations4
Issue DateDec 4, 2025
Product TypeDrugs
StatusOpen
Letter Details
Firm
3D Imaging Drug Design and Development LLC
Location
Marc S. Berridge, Ph.D.
President
3D Imaging Drug Design and Development LLC
9015 Carti Way
Little Rock , AR 72205
United States
FEI Number
3009143510
Country
United States
Issue Date
December 04, 2025
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
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.
3D Imaging Drug Design and Development LLC FDA Warning Letter, December 4, 2025
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