FDA Inspection
Nuclein LLCNuclein LLC – FDA Inspection, Jan 13, 2026
Record Details
This FDA Inspection record concerns Nuclein LLC, with an inspection on January 13, 2026, issued by the Dallas District Office, covering medical devices & rad health.
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ID · 9a3d6d70-7f35-4cf0-9800-8bf04b71c4c4
Inspection Facts
- Inspection number
- 1286088
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
3- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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