# FDA 483 - US Infusion, Inc. - March 06, 2023

Source: https://www.globalkeysolutions.net/records/483/us-infusion-inc/b165e212-36fb-4fe7-89a1-ee77a35897df

> FDA 483 for US Infusion, Inc. on March 06, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: US Infusion, Inc.
- Inspection Date: 2023-03-06
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: US Infusion, Inc. in South Miami, FL, a specification developer, was inspected by the FDA and received two observations. The inspection revealed deficiencies in establishing adequate quality agreements with contract manufacturers and in documenting corrective and preventive actions for product complaints, specifically regarding leaking IV administration sets.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/ronald-ifraimov/b4ce8b79-3fa2-4862-b7a4-68e14e45d87a)

Company: https://www.globalkeysolutions.net/companies/us-infusion-inc/ee4518b7-cb63-4711-b5d4-138d6b1ec169

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