# FDA 483 - nexAir LLC - January 12, 2024

Source: https://www.keypedia.com/records/483/nexair-llc/fbb8694b-575c-4e2d-befd-dfb78303baed

> FDA 483 for nexAir LLC on January 12, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: nexAir LLC
- Inspection Date: 2024-01-12
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of nexAir LLC in Okeechobee, FL, a medical gas manufacturer, identified significant shortcomings in its quality control unit. The firm's written procedures for critical operations like filling, quarantine, annual product reviews, and label storage were either not fully followed or contained conflicting information. These deficiencies indicate a need for improved adherence to and clarity in quality system processes.

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/steven-a-brettler/2a356468-f9da-4b68-a3a1-472567e58e45)

Company: https://www.keypedia.com/companies/nexair-llc/2e0c3269-ea10-4e18-bf22-0b106d31d0cc

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6