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FDA Writes Up CRL to ADMA Biologics Over Inspection Findings

August 5, 2016

The FDA has rejected ADMA Biologics candidate for treatment of primary humoral immunodeficiency disease due to manufacturing deficiencies.

In a complete response letter declining the company’s BLA submission for RI-002, the agency pointed to problems with three contract manufacturers hired by ADMA.

ADMA said that the company hired to produce the drug failed an inspection, deficiencies were reported with another contract manufacturer hired to handle fill and finish and a third contractor that tested the products was cited for compliance issues.

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