# FDA 483 - Nuclein LLC - January 13, 2026

Source: https://www.keypedia.com/records/483/nuclein-llc/ea90befd-bfb5-44b5-bda9-1945f985609d

> FDA 483 for Nuclein LLC on January 13, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nuclein LLC
- Inspection Date: 2026-01-13
- Product Type: device
- Office Name: Dallas District Office
- Summary: An FDA inspection of Nuclein LLC in Austin, TX, a manufacturer of a Class II medical device for diagnosing respiratory viruses, revealed significant quality system deficiencies. The firm failed to adequately investigate device complaints, particularly those involving invalid results and motor errors, due to flawed internal thresholds. Additionally, the inspection found inadequate risk analysis for hazards like delayed results leading to delayed treatment, and sampling plans for final acceptance testing lacked valid statistical rationale.

## Related Officers

- [Katherine M. Thames](https://www.keypedia.com/people/katherine-m-thames/06a4ece2-7417-42d5-93ab-d744aa5279eb)

Company: https://www.keypedia.com/companies/nuclein-llc/676f17bb-67c9-4e1f-95fe-e0d4acc57e53

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9