ADMA Biologics Reports Successful Close-Out of its April 2018 FDA Compliance Inspection

ADMA Biologics (NASDAQ:ADMA) has announced that it has received formal notice from the US Food and Drug Administration (FDA) of the successful close-out for the April 2018 compliance inspection of its Boca Raton facility.

As quoted in the press release:

 This is the first EIR issued to the site since 2012.

The EIR received by the Company contains detailed information about the April 2018 FDA inspection, discussions had with the investigators, requests for clarification and information, as well as a summary of potential next steps for the review of the Prior Approval Supplement (“PAS”) for BIVIGAM®.  According to FDA guidance, when the Agency concludes that an inspection is “closed” under 21 CFR 20.64(d) (3), it releases a copy of the EIR to the inspected establishment.

The EIR discusses many improvements and resolutions made by the Company to the majority of observations previously existing from the 2014 and 2016 FDA inspections of the Boca Raton, FL facility while owned and operated by Biotest Pharmaceuticals Corporation (“Biotest”).  The Agency has requested specific clarification to certain historical inspectional deficiencies (from 2014 and 2016), some of which, the Company believes, will be addressed during the ongoing review of the PAS for BIVIGAM®.  The EIR states that the FDA investigators were unable to review real time production of BIVIGAM® during the inspection and the report notes that the PAS had not yet been on file at the time of the April 2018 inspection. The Company believes that in order for FDA to make a final determination regarding the 2014 Warning Letter Close-Out, a review of the PAS submission for BIVIGAM® as well as a potential Pre-Approval Inspection (“PAI”) of the manufacturing process may be required.  Based on separate informal correspondence received between the Company and FDA staff within the Center for Biologics Evaluation and Research (“CBER”), the Company has been informed that its compliance status is currently Voluntary Action Indicated (“VAI”), which remains to be confirmed with CBER’s Office of Compliance and Biologics Quality (“OCBQ”).  In addition, the FDA has stated to the Company that the 483 responses have been reviewed and corrective actions will be assessed at the next FDA inspection of the establishment, which is anticipated by the Company to occur on or before the end of April 2020.

Click here to read the full press release.