FDA Inspection 1286088 — Nuclein LLC
The FDA completed an inspection of Nuclein LLC on Jan 13, 2026 in Austin, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jan 13, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Austin, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |