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

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.