# FDA 483 - Avantec Vascular Corporation - January 10, 2020

Source: https://www.globalkeysolutions.net/records/483/avantec-vascular-corporation/68310006-fdf8-4a98-bfd0-de4822932aef

> FDA 483 for Avantec Vascular Corporation on January 10, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Avantec Vascular Corporation
- Inspection Date: 2020-01-10
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Avantec Vascular Corporation in Sunnyvale, CA, a medical device manufacturer, received a Form 483 with three observations during an FDA inspection. The firm was cited for inadequate documentation of corrective and preventive actions for nonconforming material, failure to revalidate a manufacturing process after changes, and an insufficient risk analysis for its Captus Vascular Retrieval System. These findings indicate deficiencies in the company's quality system regarding CAPA, process control, and design control.

## Related Documents

- [483 - 2023-01-26](https://www.globalkeysolutions.net/records/483/avantec-vascular-corporation/1e61493d-ecc9-41b0-ada1-5fa49d33b510)

## Related Officers

- [Amogh Pathi](https://www.globalkeysolutions.net/people/amogh-pathi/1325ce17-ca08-4cfb-818e-37889eccb31b)
- [investigator](https://www.globalkeysolutions.net/people/eric-j-heinze/f16828ab-f1e0-4556-bccc-700d93965b86)

Company: https://www.globalkeysolutions.net/companies/avantec-vascular-corporation/89408fdd-d7dd-444c-845f-94f23803a25b

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