# FDA 483 - U-Smell-It Llc - May 22, 2025

Source: https://www.keypedia.com/records/483/u-smell-it-llc/51f5d63d-b284-49b8-9678-9a592a0fc8d5

> FDA 483 for U-Smell-It Llc on May 22, 2025. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: U-Smell-It Llc
- Inspection Date: 2025-05-22
- Product Type: device
- Office Name: New England District Office
- Summary: U-Smell-It Llc in Guilford, CT, was inspected on May 22, 2025, and received a Form FDA-483. The inspection revealed a significant deficiency concerning medical device labeling, specifically the absence of a Unique Device Identifier (UDI) for their Class II U-Smell-It Test. This indicates non-compliance with regulatory requirements for device identification.

## Related Officers

- [Katarzyna Plona](https://www.keypedia.com/people/katarzyna-plona/ea20d6c6-5d2d-41a0-a755-0647fb9f3250)

Company: https://www.keypedia.com/companies/u-smell-it-llc/ead97a45-e7f5-4d00-ad1f-c8a2813ad301

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144