Warning letter
InVia Fertility Specialists, PLLC: warning letter of Jun 13, 2025
FDA warning letter 710632 · Center for Biologics Evaluation and Research
Key facts
| Reference number | 710632 |
|---|---|
| Company | InVia Fertility Specialists, PLLC |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | Jun 13, 2025 |
| Posted date | Jul 1, 2025 |
| Issuing office | Center for Biologics Evaluation and Research |
| Product type | Biologics |
| CFR sections cited | 1271.3(h), 1271, 1271.3(s), 1271.47(a), 1271.75, 1271.75(a)(1), 1271.80, 1271.85, 1271.155, 1271.50(a), 1271.60(a), 1271.65(b)(2) and 3 more |
| Inspection city | Hoffman Estates |
| Inspection ZIP | 60169 |
| Inspection start date | Jan 28, 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: