# FDA 483 - Zavation - June 20, 2019

Source: https://www.globalkeysolutions.net/records/483/zavation/929978b5-d6f9-4db3-a4c8-21523c7bee66

> FDA 483 for Zavation on June 20, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zavation
- Inspection Date: 2019-06-20
- Product Type: device
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Zavation Medical Products, LLC in Flowood, MS, identified a significant issue regarding the timely submission of Medical Device Reports (MDRs). The firm failed to submit MDRs within the required 30-day timeframe for device malfunctions that could potentially lead to death or serious injury if they recurred. This indicates a critical lapse in the company's post-market surveillance and reporting procedures.

## Related Officers

- [Nicholas Z. Lu](https://www.globalkeysolutions.net/people/nicholas-z-lu/17448aca-e316-424c-b7b2-88c8baffc359)

Company: https://www.globalkeysolutions.net/companies/zavation/2763292a-0570-495c-bb67-ba49772ed693

Office: https://www.globalkeysolutions.net/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea