# FDA 483 - Hemarus, LLC - March 12, 2020

Source: https://www.globalkeysolutions.net/records/483/hemarus-llc/c77ef3e1-e1d9-40be-a0e8-77959f4f87cb

> FDA 483 for Hemarus, LLC on March 12, 2020. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hemarus, LLC
- Inspection Date: 2020-03-12
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Hemarus, LLC, a plasma donor center in Jacksonville, FL, was inspected by the FDA from March 9-12, 2020. The inspection revealed issues with equipment standardization, specifically a hematocrit testing machine, and a lack of proper donor notification for transfusion-transmitted infection test results. Additionally, a phlebotomist was observed compromising the sterility of a venipuncture site.

## Related Officers

- [Investigator at U.S.FDA](https://www.globalkeysolutions.net/people/barbara-t-carmichael/4c451805-e327-450d-b2e5-48a40f6232fe)

Company: https://www.globalkeysolutions.net/companies/hemarus-llc/a4878d3e-e71b-48fd-83ef-db106aea14e3

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