# FDA 483 - Embolx, Inc. - January 19, 2023

Source: https://www.globalkeysolutions.net/records/483/embolx-inc/49a0adac-d7b2-4906-b611-90d855f6bf9b

> FDA 483 for Embolx, Inc. on January 19, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Embolx, Inc.
- Inspection Date: 2023-01-19
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Embolx, Inc. in Sunnyvale, CA, a specification developer, received a Form 483 with six observations primarily concerning deficiencies in their quality system. Key issues include inadequate medical device reporting procedures, incomplete complaint investigation records, insufficient CAPA documentation and effectiveness checks, and failures in management review, quality audits, and supplier evaluation processes. The observations indicate systemic issues in maintaining an effective quality system.

## Related Officers

- [Jeffrey S Buckser](https://www.globalkeysolutions.net/people/jeffrey-s-buckser/deea4f9e-858f-4325-828e-56044c40a570)

Company: https://www.globalkeysolutions.net/companies/embolx-inc/3d06d7b2-85d3-4016-a1dd-ec60b5d4c00b

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b