FDA Inspection 1232499 — Center for Reproductive Medicine & Robotic Surgery LLC
The FDA completed an inspection of Center for Reproductive Medicine & Robotic Surgery LLC on March 11, 2024 in Saint Louis, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 11, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Saint Louis, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12496 | 21 CFR 1271.85(b)(2) | SOP for release; reactive for CMV |