# FDA 483 - GlobalMed Holdings, LLC - October 25, 2024

Source: https://www.globalkeysolutions.net/records/483/globalmed-holdings-llc/83f8f500-706b-4a94-b8f7-59e7fd7b16a2

> FDA 483 for GlobalMed Holdings, LLC on October 25, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GlobalMed Holdings, LLC
- Inspection Date: 2024-10-25
- Product Type: device
- Office Name: Denver District Office
- Summary: This FDA Form 483 was issued to GlobalMed Holdings, LLC, a medical device manufacturer in Scottsdale, AZ, following an inspection. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate complaint handling, incomplete device master records, and poor documentation of corrective and preventive actions. Further issues involved insufficient control of nonconforming products, unvalidated software, and incorrect device listing information, indicating systemic quality control problems.

## Related Officers

- [Scott D. Stevens](https://www.globalkeysolutions.net/people/scott-d-stevens/8d5a611a-4f0c-4e3a-9da7-3c872b08f91e)

Company: https://www.globalkeysolutions.net/companies/globalmed-holdings-llc/987a8ef8-91f0-4575-94b3-b3db2056e901

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face