# FDA 483 - Noah Medical Corporation - November 26, 2024

Source: https://www.globalkeysolutions.net/records/483/noah-medical-corporation/42eea2fb-80a0-4959-9896-1e9b2ba19556

> FDA 483 for Noah Medical Corporation on November 26, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Noah Medical Corporation
- Inspection Date: 2024-11-26
- Product Type: device
- Office Name: San Francisco District Office
- Summary: Noah Medical Corporation in San Jose, CA, received a Form FDA 483 with 13 observations during an inspection from 10/26/2024 to 11/26/2024. The inspection revealed significant deficiencies in medical device reporting, complaint handling, CAPA procedures, design controls, process validation, supplier management, nonconforming product control, rework procedures, device history records, correction/removal reporting, personnel training, and UDI database registration for their Galaxy System. These issues indicate a systemic breakdown in their quality system, particularly concerning patient safety and regulatory compliance.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/matthew-m-vernon/f77e8c18-8614-49e3-9b19-3327b7fe7648)
- [Nga T. Ho](https://www.globalkeysolutions.net/people/nga-t-ho/7c7d96a2-9b2c-4966-8dc2-ee20ca024be1)

Company: https://www.globalkeysolutions.net/companies/noah-medical-corporation/1109c4d2-a2fd-467d-b7f6-e8898af2fa3e

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df