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

Source: https://www.globalkeysolutions.net/records/483/the-advanced-ivf-institute-charles-e-miller-md-associates/8222d5b2-79af-42b4-ba2b-67fb96f12f70

> FDA 483 for The Advanced IVF Institute: Charles E. Miller, M.D. & Associates on April 25, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: The Advanced IVF Institute: Charles E. Miller, M.D. & Associates
- Inspection Date: 2025-04-25
- Product Type: other
- Office Name: Chicago District Office
- Summary: 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.

## Related Officers

- [Gabryelle J. Solverud](https://www.globalkeysolutions.net/people/gabryelle-j-solverud/29c4452f-2f7a-4325-8f8d-7046fcb4690f)
- [FDA_PERSONNEL](https://www.globalkeysolutions.net/people/zoey-a-trombley/cb7ac4dd-bc47-4b51-8fef-a485b122c921)

Company: https://www.globalkeysolutions.net/companies/the-advanced-ivf-institute-charles-e-miller-md-associates/71fa96b3-c843-4e07-b13a-e50643fa591f

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669