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483
•Hemarus, LLC•March 12, 2020

Hemarus, LLC – FDA 483, Mar 12, 2020

Record Details

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.

Company
Hemarus, LLC
Inspection date
March 12, 2020
Product type
biologics
Office
Office of Medical Device and Radiological Health Division II
Person
  • Barbara T. Carmichael (Investigator at U.S.FDA)
View Company Profile

ID · c77ef3e1-e1d9-40be-a0e8-77959f4f87cb

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