Warning letter
GenoGenix LLC: warning letter of Jan 20, 2026
FDA warning letter 718739 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 718739 |
|---|---|
| Company | GenoGenix LLC |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Issue date | Jan 20, 2026 |
| Posted date | Mar 3, 2026 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| CFR sections cited | 211.192, 200.10(b), 201.115, 210.1(b), 211.22(a), 211.25(a), 211.42(c)(10), 211.42(c)(10)(iv), 211.84(d)(1), 211.100(a), 211.113(b), 211.115(a) and 3 more |
| Inspection city | Boca Raton |
| Inspection ZIP | 33431 |
| Inspection start date | Jul 14, 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: