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

The FDA issued a Warning Letter to 3D Imaging Drug Design and Development LLC following an inspection from June 9 to 13, 2025, revealing significant violations of Current Good Manufacturing Practice (CGMP) for positron emission tomography (PET) drugs, outlined in 21 CFR part 212. The inspection found that the company"s PET drug products, including Fludeoxyglucose F18, were adulterated due to inadequate manufacturing methods, facilities, and controls. Key issues included a facility design unsuitable for preventing contamination, with aseptic connections performed in open bench areas and a hot cell in disrepair with visible rust and residue. Environmental monitoring was found to be insufficient, lacking monitoring in critical areas and having inappropriate alert and action levels. Furthermore, production and process controls were deficient, with operators observed improperly gowned, exposing skin and hair during sterile operations, and a failure to adequately requalify operators annually for aseptic processing techniques. The company also failed to properly update the drug listing for Fludeoxyglucose F18 as required by 21 U.S.C. 360(j) and 21 CFR part 207. Required actions include a comprehensive risk assessment of contamination hazards, a detailed remediation plan, updated procedures for aseptic connections, an independent assessment of the environmental monitoring program, and revised action levels for critical environments.