Warning letter
HTO Nevada, Inc. dba Kirkman: warning letter of Jan 27, 2026
FDA warning letter 719074 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 719074 |
|---|---|
| Company | HTO Nevada, Inc. dba Kirkman |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Jan 27, 2026 |
| Posted date | Feb 3, 2026 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| CFR sections cited | 211.166(a), 211.180(e), 211.22, 211.22(a), 211.22(d), 211.34, 211.100(a) |
| Inspection city | Lake Oswego |
| Inspection ZIP | 97035 |
| Inspection start date | Aug 18, 2025 |
| 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: