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ADMA Biologics' Fla. manufacturing facility gets US FDA clearance

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ADMA Biologics' Fla. manufacturing facility gets US FDA clearance

ADMA Biologics Inc. said the U.S. Food and Drug Administration cleared its manufacturing facility in Boca Raton, Fla.

The regulator updated the facility's compliance status to voluntary action indicated, which means that objectionable conditions were found and documented but that the FDA will not make or recommend regulatory action.

Following the improved compliance status, ADMA intends to resubmit its biologics license application for its lead drug, RI-002, in the third quarter of 2018.

RI-002 is an investigational treatment of primary humoral immunodeficiency disease, a group of diseases caused by impaired humoral immunity, or antibody-mediated immune responses.