FDA 483 - The Advanced IVF Institute: Charles E. Miller, M.D. & Associates - April 25, 2025
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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.
- Inspection Date
- April 25, 2025
- Product Type
- Other
ID · 8222d5b2-79af-42b4-ba2b-67fb96f12f70