FDA 483 - The Advanced IVF Institute: Charles E. Miller, M.D. & Associates - April 25, 2025

The Advanced IVF Institute: Charles E. Miller, M.D. & Associates in Naperville, IL, received a Form 483 with four observations related to deficiencies in donor screening and record-keeping for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to adequately screen donors for communicable diseases, properly document donor eligibility, state reasons for donor ineligibility, and confirm CLIA-certified laboratory testing. These issues highlight significant concerns in their donor management and quality system.