Warning letter
Green Valley Fertility Partners: warning letter of Dec 3, 2025
FDA warning letter 720249 · Center for Biologics Evaluation and Research (CBER)
Key facts
| Reference number | 720249 |
|---|---|
| Company | Green Valley Fertility Partners |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | Dec 3, 2025 |
| Posted date | Dec 16, 2025 |
| Issuing office | Center for Biologics Evaluation and Research (CBER) |
| Product type | Biologics |
| CFR sections cited | 1271.90(c), 1271, 1271.55(a), 1271.55(a)(1), 1271.55(c), 1271.75(a)(1), 1271.75, 1271.80, 1271.85, 1271.155, 1271.50(a), 1271.60(a) and 3 more |
| Inspection city | Henderson |
| Inspection ZIP | 89052 |
| Inspection start date | May 8, 2025 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: