# FDA 483 - Q30 Sports Science, Llc - October 12, 2023

Source: https://www.keypedia.com/records/483/q30-sports-science-llc/4248db91-6167-46cc-a69c-25f1d233cbf2

> FDA 483 for Q30 Sports Science, Llc on October 12, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Q30 Sports Science, Llc
- Inspection Date: 2023-10-12
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Q30 Sports Science, Llc, a specification developer in Norwalk, CT, was inspected regarding its medical device operations. The inspection revealed two significant issues: a failure to document rationales for not investigating complaints for its Q-Collar device, and a lack of registration for the Q-Collar's Unique Device Identifiers (UDIs) in the GUDID database. These observations indicate non-compliance with medical device record-keeping and registration requirements.

## Related Officers

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

Company: https://www.keypedia.com/companies/q30-sports-science-llc/08fce9f1-1aa1-4d1f-a775-9d6ee9de913f

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94