FDA Inspection 1289290 — Longhorn Vaccines And Diagnostics LLC
The FDA completed an inspection of Longhorn Vaccines And Diagnostics LLC on Oct 30, 2025 in Bethesda, MD. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Oct 30, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Bethesda, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3104 | 21 CFR 820.30(j) | Design history file |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |