FDA Inspection 1267880 — The Advanced IVF Institute: Charles E. Miller, M.D. & Associates
The FDA completed an inspection of The Advanced IVF Institute: Charles E. Miller, M.D. & Associates on Apr 25, 2025 in Naperville, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 25, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Naperville, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12238 | 21 CFR 1271.55(b)(1) | Statement re: certified testing lab |
| 12241 | 21 CFR 1271.55(b)(4) | Reasons for ineligibility on summary |
| 12246 | 21 CFR 1271.55(d)(1)(iii) | Documentation--determination, by whom, date |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |