# FDA 483 - Flexbar Machine Corp - April 04, 2025

Source: https://www.globalkeysolutions.net/records/483/flexbar-machine-corp/a93ab201-cbe9-4e38-a679-392dec0ef7fc

> FDA 483 for Flexbar Machine Corp on April 04, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Flexbar Machine Corp
- Inspection Date: 2025-04-04
- Product Type: device
- Office Name: New York District Office
- Summary: An FDA inspection of Flexbar Machine Corp in Islandia, NY, a medical device manufacturer and importer, revealed a significant deficiency in their quality system. The firm failed to maintain written Medical Device Reporting (MDR) procedures and lacked the necessary electronic infrastructure for reporting serious injuries and deaths. This indicates a critical gap in their compliance with medical device reporting requirements.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

Company: https://www.globalkeysolutions.net/companies/flexbar-machine-corp/9998315c-237d-4866-98c5-8958437449d3

Office: https://www.globalkeysolutions.net/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d