# FDA 483 - Coeur Inc. - March 29, 2018

Source: https://www.globalkeysolutions.net/records/483/coeur-inc/0d16c62e-18a8-4331-be1a-b0c27d5062ad

> FDA 483 for Coeur Inc. on March 29, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Coeur Inc.
- Inspection Date: 2018-03-29
- Product Type: device
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Coor, Inc., a Class II Medical Devices Manufacturer in Washington, NC, revealed significant deficiencies in their quality system. Observations included inadequate procedures for corrective and preventive actions, insufficient process validation documentation for manufacturing equipment, and failures in document control. Additionally, the firm lacked proper procedures for equipment maintenance and mold management.

## Related Officers

- [Monica C. Burgos Garcia](https://www.globalkeysolutions.net/people/monica-c-burgos-garcia/d73d6ad6-4158-4c12-a0bf-6f5721db3400)

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

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