# FDA 483 - Levo Medical Corporation - May 15, 2024

Source: https://www.keypedia.com/records/483/levo-medical-corporation/5dabf21e-cad4-4ae1-bf60-8eee2a6a831a

> FDA 483 for Levo Medical Corporation on May 15, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Levo Medical Corporation
- Inspection Date: 2024-05-15
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of Levo Medical Corporation, a medical device manufacturer in Victoria, identified significant deficiencies in their quality system. The firm's procedures for management review were found to be inadequately established, specifically lacking clear definitions for required management members. Additionally, procedures for complaint handling, including the definition of key terminology essential for medical device reporting, were not adequately established, and adverse event reportability evaluations were poorly documented.

## Related Officers

- [investigator](https://www.keypedia.com/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.keypedia.com/companies/levo-medical-corporation/c15e024e-ebe9-43bc-a9b0-a861e00c55a5

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4