FDA 483 - Gobiquity, Inc - June 15, 2023
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Gobiquity, Inc. in Santa Clarita, CA, a Class II medical device manufacturer, was cited with two observations during an FDA inspection from June 13-15, 2023. The inspection revealed deficiencies related to the Unique Device Identification (UDI) system, specifically concerning the submission of device information to the Global Unique Device Identification Database (GUDID) and the establishment of adequate UDI labeling procedures for their GoCheckKids photoscreeners. These issues indicate significant concerns with device traceability and regulatory compliance.
ID · 6730c4a9-d5ab-45bc-9bc7-9e2901fb37de