FDA Releases ADMA Biologics Form 483 as Company Announces VAI Status

Regulatory NewsRegulatory News | 21 September 2018 |  By 

The US Food and Drug Administration (FDA) this week unveiled a Form 483 from April for ADMA Biologics, a company that previously received a complete response letter related to manufacturing deficiencies.

Earlier this month and prior to the 483’s release, however, ADMA said FDA’s inspection database classification website has been updated and “confirms ADMA’s compliance status has improved to Voluntary Action Indicated (VAI).”

FDA explains the VAI designation as: “Objectionable conditions were found but the problems do not justify further regulatory action. Any corrective action is left to the investigator to take voluntarily.”

Adam Grossman, president and CEO of ADMA, said: “We are excited to finally be in a position to resubmit our Biologics License Application for RI-002 during the third quarter of 2018.”

That update followed the company’s receipt of complete response letter (CRL) in July 2016 for its lead biologic, a treatment for Primary Immune Deficiency Disease. According to ADMA, FDA identified in the CRL “outstanding inspection issues and deficiencies at ADMA’s third-party contract manufacturers, including its contract drug substance and product manufacturer, its contract fill and finisher and compliance issues with a third-party contract testing laboratory, and requested documentation of corrections for a number of those issues.”

Form 483

Following a 10-day inspection in April, FDA cited the company with eight observations in the redacted Form 483, the first of which deals with the Boca Raton, FL-based site’s failure to prevent “unauthorized access of changes to data and to provide adequate controls to prevent omissions of data.”

“Data can be deleted from the hard drive of computers associated with analytical equipment,” FDA said.

“Responsibilities of the quality unit are not in writing,” was the fourth observation, while the fifth dealt with studies not demonstrating that the firm’s equipment does not alter the quality of drug substances.


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