Warning letter
AseptiKits, LLC: warning letter of Jun 4, 2026
FDA warning letter 728184 · Center for Devices and Radiological Health
Key facts
| Reference number | 728184 |
|---|---|
| Company | AseptiKits, LLC |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Issue date | Jun 4, 2026 |
| Posted date | Jun 30, 2026 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 880.5440(b), 880.5440(a) |
| Inspection city | North Salt Lake |
| Inspection ZIP | 84054 |
| Inspection start date | Nov 11, 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: