# FDA 483 - Advanced Vascular Dynamics - April 18, 2016

Source: https://www.globalkeysolutions.net/records/483/advanced-vascular-dynamics/8417ae2f-4a06-4888-a26e-03ab43838156

> FDA 483 for Advanced Vascular Dynamics on April 18, 2016. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Advanced Vascular Dynamics
- Inspection Date: 2016-04-18
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Ventor Technologies, Inc., a medical device manufacturer in Milwaukie, OR, was cited for three observations during an FDA inspection. The firm failed to adequately establish procedures for finished device acceptance, including sterilization process criteria and quarantine times. Additionally, the company did not properly investigate complaints involving device failures and lacked adequate procedures for receiving, reviewing, and evaluating complaints.

## Related Officers

- [Jeff A Card](https://www.globalkeysolutions.net/people/jeff-a-card/9fc857af-44f8-4e84-ae2e-5087538fc916)
- [President and CEO](https://www.globalkeysolutions.net/people/james-d-hildreth/1fb2f65a-9905-4848-83a3-16cb1f9e2179)

Company: https://www.globalkeysolutions.net/companies/advanced-vascular-dynamics/80591d24-0487-4d54-819d-081da32ebeef

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822