3D Imaging Drug Design and Development LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

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).

Passage 2

Your firm failed to have laboratory methods suitable for their intended use and sufficiently sensitive, specific, accurate, and reproducible (21 CFR 212.60).

Passage 3

Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.