FDA Inspection 1313432 — New Infertility Center of St Louis
The FDA completed an inspection of New Infertility Center of St Louis on April 22, 2026 in Chesterfield, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 22, 2026
- Fiscal Year
- 2026
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Chesterfield, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12222 | 21 CFR 1271.47(a) | Design of procedures to ensure compliance |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |