# FDA 483 - Cardiva Medical, Inc. - July 21, 2023

Source: https://www.globalkeysolutions.net/records/483/cardiva-medical-inc/3f247ef8-a500-410a-a3e5-62143fe03659

> FDA 483 for Cardiva Medical, Inc. on July 21, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cardiva Medical, Inc.
- Inspection Date: 2023-07-21
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Cardiva Medical, Inc. in Santa Clara, CA, identified four significant quality system deficiencies. These included inadequate procedures for management review, incomplete documentation for complaint investigations, insufficient documentation of corrective and preventive actions (CAPA) and their effectiveness, and undocumented personnel training effectiveness. The findings highlight systemic issues in maintaining a robust quality management 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/cardiva-medical-inc/d2c13d97-eb8f-4b56-bcf4-052d6081107f

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