# FDA 483 - Gobiquity, Inc - June 15, 2023

Source: https://www.globalkeysolutions.net/records/483/gobiquity-inc/6730c4a9-d5ab-45bc-9bc7-9e2901fb37de

> FDA 483 for Gobiquity, Inc on June 15, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gobiquity, Inc
- Inspection Date: 2023-06-15
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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.

## Related Documents

- [483 - 2026-02-12](https://www.globalkeysolutions.net/records/483/gobiquity-inc/7f306094-d880-4f6a-bf73-7f98bc531833)

## Related Officers

- [Kelvin Cheung](https://www.globalkeysolutions.net/people/kelvin-cheung/ded61aee-4b4b-4049-a67c-19d971475be7)

Company: https://www.globalkeysolutions.net/companies/gobiquity-inc/d3a6698c-d438-4e5b-a7cb-d10e8882eceb

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6