# FDA 483 - InnAVasc Medical, Inc. - June 06, 2019

Source: https://www.globalkeysolutions.net/records/483/innavasc-medical-inc/5da3c528-abb9-4485-a79e-abc1cfacfc0e

> FDA 483 for InnAVasc Medical, Inc. on June 06, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: InnAVasc Medical, Inc.
- Inspection Date: 2019-06-06
- Product Type: device
- Office Name: Atlanta District Office
- Summary: An FDA inspection of InnaVasc Medical, Inc. in Durham, NC, revealed significant deficiencies in record-keeping for adverse device effects. The firm failed to maintain complete records of verbal reports from clinical sites concerning anticipated or unanticipated device events, including device abandonment and explant. This indicates a serious lapse in tracking critical safety information for investigational devices.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/laura-l-staples/fe59bc9c-b439-4dd8-8c8a-5fac6f7733f8)

Company: https://www.globalkeysolutions.net/companies/innavasc-medical-inc/4547ab95-819d-42b9-9f62-ff8b03fbfa35

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