# FDA 483 - ARC Medical Inc. - November 14, 2019

Source: https://www.keypedia.com/records/483/arc-medical-inc/a259495d-48e0-4ed4-9210-dc6b02b4802f

> FDA 483 for ARC Medical Inc. on November 14, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ARC Medical Inc.
- Inspection Date: 2019-11-14
- Product Type: device
- Office Name: Atlanta District Office
- Summary: An FDA inspection of ARC Medical Inc., a medical device repackager/relabeler in Tucker, GA, identified two significant observations. The firm failed to adequately establish procedures for ensuring purchased products and services conform to specified requirements, including defining supplier controls. Additionally, the company did not adequately establish or implement training procedures, with no documented employee training for new quality policies and procedures.

## Related Officers

- [Miaja Umaedi](https://www.keypedia.com/people/miaja-umaedi/0a41661f-08bb-4523-ab09-b17e230068e0)

Company: https://www.keypedia.com/companies/arc-medical-inc/b89bf347-8e60-4fd7-b5f7-323ecb23509c

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7