Warning letter
Prodrome Sciences USA, LLC: warning letter of Jan 8, 2026
FDA warning letter 717959 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 717959 |
|---|---|
| Company | Prodrome Sciences USA, LLC |
| Subject | Sponsor/Unapproved Misbranded |
| Issue date | Jan 8, 2026 |
| Posted date | Jan 20, 2026 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| CFR sections cited | 312.20(a), 312, 312.2, 312.2(a), 312.20, 312.40 |
| Inspection city | Temecula |
| Inspection ZIP | 92590 |
| Inspection start date | Dec 17, 2024 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 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: