# FDA 483 - GUIDEMIA TECHNOLOGIES LLC - July 06, 2026

Source: https://www.keypedia.com/records/483/guidemia-technologies-llc/99cb4f89-202c-430c-a55e-440d9af286cb

> FDA 483 for GUIDEMIA TECHNOLOGIES LLC on July 06, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GUIDEMIA TECHNOLOGIES LLC
- Inspection Date: 2026-07-06
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of GUIDEMIA TECHNOLOGIES LLC, a medical device manufacturer in Buena Park, CA, revealed significant quality system deficiencies. The firm failed to adequately maintain records for corrective actions and complaint handling, and lacked proper personnel training. Additionally, the company did not register its devices with the Global Unique Device Identification Database (GUDID).

## Related Officers

- [Jordan I. Abel](https://www.keypedia.com/people/jordan-i-abel/9cdc8877-ab20-4c0c-a17e-a8534d4f13f2)
- [Joseph C. Onyeike](https://www.keypedia.com/people/joseph-c-onyeike/cbd4ec5e-e545-4f3a-b0cb-d872af0fc2de)

Company: https://www.keypedia.com/companies/guidemia-technologies-llc/6391926f-e7ee-40f6-8fe0-8d7e5e542106

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