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# ADMA Bio Gets FDA Close Out on Recent Inspection
- URL: https://www.fdaweb.com/adma-bio-gets-fda-close-out-on-recent-inspection/
- Published: 2018-07-26T12:00:00.000Z
- Updated: 2026-09-15T00:21:57.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5141972

FDA has told ADMA Biologics that it has closed out an April Establishment Inspection Report (EIR) issued after a compliance inspection at the firm’s Boca Raton, FL production facility. The EIR cited requests for clarification and information, as well as a summary of potential next steps for the review of a Prior Approval Supplement (PAS) for Bivigam (human immune globulin 10% liquid).  
  
“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,” ADMA says. The agency has requested “specific clarification of 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 4/2018 inspection.”

  
Additionally, the company says it elieves that in order for FDA to make a final determination on the 2014 Warning Letter close-out, a review of the PAS submission as well as a potential pre-approval inspection of the manufacturing process may be required. Based on separate correspondence from the agency, ADMA’s current compliance status is “Voluntary Action Indicated.” Recent Form 483 responses have been reviewed and corrective actions will be assessed at the next FDA inspection of the establishment, it says.