# FDA WARNING_LETTER - Nobles Medical Technology II, Inc. - October 20, 2023

Source: https://www.globalkeysolutions.net/records/warning_letter/nobles-medical-technology-ii-inc/b2385a0f-ae37-467a-bcb6-3a58e1391cc2

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

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## Details

- Record Type: WARNING_LETTER
- Company Name: Nobles Medical Technology II, Inc.
- Inspection Date: 2023-10-20
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: The FDA issued a Warning Letter to Nobles Medical Technology II, Inc. on January 26, 2024, following an inspection from October 16-20, 2023. The inspection assessed compliance as a sponsor for the "STITCH" clinical study (IDE G180296) of the NobleStitch EL device.

The letter cited serious violations of 21 CFR Part 812 (Investigational Device Exemptions). Key deficiencies include:

1.  **Failure to ensure proper monitoring and IRB review/approval (21 CFR 812.40):** The firm failed to provide investigators with necessary information (signed protocols, brochures, labeling), ensure proper study monitoring, and provide documentation of IRB approvals and continuing review for multiple sites.
2.  **Failure to select qualified investigators and monitors (21 CFR 812.43(a) and (d)):** The firm did not provide documentation (e.g., CVs) to show that clinical investigators or monitors were qualified by training and experience.
3.  **Failure to obtain signed investigator agreements (21 CFR 812.43(c)(4)(i)):** Signed agreements lacked a statement of the investigator’s commitment to supervise all device testing involving human subjects.
4.  **Failure to obtain financial disclosure information (21 CFR 812.43(

## Related Officers

- [Division Director](https://www.globalkeysolutions.net/people/soma-kalb/dc303fda-2408-43d5-9790-079ec1edcb29)

Company: https://www.globalkeysolutions.net/companies/nobles-medical-technology-ii-inc/1fb76094-95b3-425f-abf6-f05e950dc439

Office: https://www.globalkeysolutions.net/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7