Great news. Looks like we are close to being back in the fight. Next action will occur in OCT18. Hopefully this keeps RI-002 on track.
ADMA BIOLOGICS REPORTS SUCCESSFUL CLOSE-OUT OF ITS APRIL 2018 FDA COMPLIANCE INSPECTION
JULY 26, 2018
FDA ESTABLISHMENT INSPECTION REPORT (“EIR”) RECEIVEDRAMSEY, N.J. and BOCA RATON, Fla., July 26, 2018 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) (“ADMA” or the “Company”), a vertically integrated commercial biopharmaceutical company that manufactures, markets and develops specialty plasma-based biologics for the prevention and treatment of certain infectious diseases, announces that the Company has received formal notice from the U.S. Food and Drug Administration (the “FDA” or the “Agency”) of the successful close-out for the April 2018 compliance inspection of the Boca Raton, FL production facility. 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.
The Company’s assessment of the information received by FDA results in the following determinations:
The April 2018 compliance inspection of the Boca Raton, FL manufacturing facility has been successfully closed out. ADMA intends to implement the corrective actions represented to FDA in its accepted 483 response. The current compliance status of the Boca Raton, FL facility is “VAI”.In order for FDA to make an official determination regarding the close-out of the 2014 Warning Letter, the Company believes a complete review of the PAS and a potential PAI for BIVIGAM® should occur. The Company has been informed that the target action date for the PAS is October 25, 2018. “We are pleased that the FDA has determined our responses to be satisfactory for the April 2018 FDA compliance inspection and that the FDA has accepted our plan for remediation to their observations and closed this inspection. We believe that we have successfully remediated the production and significant compliance issues identified in the 2014 Warning Letter and subsequent 2016 cGMP inspection issued to Biotest as evidenced by the successful production of three conformance batches for BIVIGAM®, which were the basis for our June 2018 PAS submission. Furthermore, we believe that once the FDA has reviewed the PAS and performed an inspection of the manufacturing operations for BIVIGAM®, we will be in position to relaunch BIVIGAM in the U.S. and further improve our compliance status,” stated Adam Grossman, President and Chief Executive Officer of ADMA Biologics, Inc.
Mr. Grossman further stated, “We are thankful for the extraordinary efforts of our dedicated and hard-working employees who have been relentlessly committed to improving the Company’s FDA compliance status.”
The receipt of this EIR does not change the Company’s previously reported timelines for activities, regulatory submissions and approvals. The Company remains on target to have the BIVIGAM® PAS approved and the BLA for RI-002 refiled with the FDA during the second half of 2018. |
