# FDA 483 - HG Medical USA, LLC - October 28, 2021

Source: https://www.keypedia.com/records/483/hg-medical-usa-llc/77c361a3-99d9-485d-91a5-36eaa0ec6ebd

> FDA 483 for HG Medical USA, LLC on October 28, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: HG Medical USA, LLC
- Inspection Date: 2021-10-28
- Product Type: device
- Office Name: Office of Regulatory Affairs
- Summary: HG Medical USA, LLC in Huntington, WV, was inspected from October 25-28, 2021. The inspection revealed one significant observation concerning the firm's failure to adequately establish records for acceptable suppliers and contractors. Specifically, the firm did not properly approve or audit several critical suppliers of components and services, including those for endotoxin testing, manufacturing components, water treatment, and passivation equipment.

## Related Officers

- [Tiki Dixon](https://www.keypedia.com/people/tiki-dixon/b3160a2c-ef16-4fa2-b9b9-4c3a0ed17c5b)

Company: https://www.keypedia.com/companies/hg-medical-usa-llc/057a7cd6-3c4a-4f02-b680-036b3cffb2f6

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64