FDA 483 - Q30 Sports Science, Llc - October 12, 2023
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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.
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ID · 4248db91-6167-46cc-a69c-25f1d233cbf2