3D Imaging Drug Design and Development LLC — FDA Warning Letter Findings

Your facilities are not adequate to ensure the prevention of contamination of equipment or product by substances, personnel, or environmental conditions that could reasonably be expected to have an adverse effect on product quality. Procedures to ensure that all equipment is clean, suitable for its intended purposes, properly installed, maintained, and capable of repeatedly producing valid results, are not adequately followed (21 CFR 212.30(a) and (b)). Facility Suitability…

Your firm failed to have laboratory methods suitable for their intended use and sufficiently sensitive, specific, accurate, and reproducible (21 CFR 212.60). You failed to establish and follow adequate testing procedures for sterility testing of your sterile injectable PET drugs. For example, our investigator observed your operator performing sterility testing using poor aseptic technique, including opening sterile components outside of the ISO (b)(4) laminar flow hood…

Your firm failed to have adequate production and process controls to ensure the consistent production of a PET drug that meets the applicable standards of identity, strength, quality, and purity (21 CFR 212.50). You failed to ensure that your operators are appropriately gowned to adequately protect the sterile injectable PET drugs you manufacture. For example, our investigator observed exposed skin and hair on your operator during the manufacturing of FDG lot (b)(4) . The…