# FDA 483 - Nobles Medical Technology, II - October 20, 2023

Source: https://www.keypedia.com/records/483/nobles-medical-technology-ii/764d9ea3-9e0e-4dfb-ba9c-9b012c89011f

> FDA 483 for Nobles Medical Technology, II on October 20, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nobles Medical Technology, II
- Inspection Date: 2023-10-20
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Nobles Medical Technology II, Inc. in Fountain Valley, CA, was inspected as a Bioresearch Sponsor and cited for significant deficiencies in the conduct and oversight of an investigational device study. The inspection revealed issues with an international clinical trial's design, conduct, and monitoring, as well as failures in ensuring proper IRB review and obtaining investigator agreements. Additionally, the investigational device label lacked the required cautionary statement.

## Related Officers

- [Business Analyst/Provider Enrollment Specialist](https://www.keypedia.com/people/lakecha-n-lewis/39b6305d-2a9f-448b-9a14-e412b43c8522)
- [Samson O. Oluseye](https://www.keypedia.com/people/samson-o-oluseye/bfe102f5-25cb-4ed9-9e69-2ec5ec0a047f)

Company: https://www.keypedia.com/companies/nobles-medical-technology-ii/f7ec6e30-5586-4999-b994-3535f7ebd441

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