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

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.