FDA 483 - ADMA Biologics, Inc - August 03, 2021
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ADMA Biologics, Inc. in Boca Raton, FL, a licensed biological manufacturer, was cited for four observations during an FDA inspection. The findings included failures in quality control unit procedures, lack of scientific rationale for in-process specifications, inadequate facility maintenance, and deficiencies in the change control procedure. These issues indicate significant concerns regarding the firm's adherence to manufacturing and quality standards for its plasma-derived products.
ID · 8b5aec1c-3424-460c-8d86-398a3e0fbce4