# FDA 483 - EUSA Global, LLC - October 15, 2021

Source: https://www.keypedia.com/records/483/eusa-global-llc/3c4564b8-2a27-4cfd-8749-82adca29a3ab

> FDA 483 for EUSA Global, LLC on October 15, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: EUSA Global, LLC
- Inspection Date: 2021-10-15
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of EUSA Global, LLC dba Ecleris USA in Medley, FL, a contract manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for handling complaints, controlling manufacturing processes, and accepting incoming products. These issues indicate a lack of robust quality management practices.

## Related Documents

- [483 - 2026-02-06](https://www.keypedia.com/records/483/eusa-global-llc/24abca68-7e04-47f7-bf7d-6a91f466e878)

## Related Officers

- [David M. Wilkinson](https://www.keypedia.com/people/david-m-wilkinson/5e81ba03-7602-46d6-b675-26efc77d28db)

Company: https://www.keypedia.com/companies/eusa-global-llc/746f9d01-d55f-4567-9125-2809cde3e900

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6