# FDA 483 - Coeur Inc. - February 11, 2026

Source: https://www.keypedia.com/records/483/coeur-inc/b0cbc5a4-709a-479d-934f-e580ac0aaf0c

> FDA 483 for Coeur Inc. on February 11, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Coeur Inc.
- Inspection Date: 2026-02-11
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Coeur Inc., a contract manufacturer in Washington, NC, was cited with two observations during an FDA inspection. The firm failed to adequately incorporate customer complaint feedback regarding syringe breakage into its risk management processes, leaving patient and user risks unassessed. Additionally, the company did not conduct required on-site audits of a critical sterilization supplier for its Class II medical devices, indicating deficiencies in quality system controls related to product safety and supplier oversight.

## Related Documents

- [483 - 2018-03-29](https://www.keypedia.com/records/483/coeur-inc/0d16c62e-18a8-4331-be1a-b0c27d5062ad)

## Related Officers

- [Lashawn M. Elam](https://www.keypedia.com/people/lashawn-m-elam/23bee423-c2f7-4977-bc32-2d4c40fc521f)

Company: https://www.keypedia.com/companies/coeur-inc/662d02ad-f9ca-4795-84e4-c95cc022e4f5

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