This afternoon, the Food and Drug Administration completed the pre-approval inspection of the BioPort facility in Lansing, Mich. An inspection report (FD-483) was issued to the firm, and it contained seven inspectional observations that needed to be addressed. BioPort satisfactorily addressed many of these observations during the inspection.

Based upon the firm's submissions, the observations during the inspection, and pending an adequate response to the inspectional observations, FDA's Center for Biologics Evaluation and Research (CBER) will make a decision on the approvability of the BioPort supplemental Biologics License Application (BLA).

Before new Anthrax Vaccine Adsorbed can be lot released and available for routine shipment, however, FDA must also approve a supplemental BLA for BioPort's contract filling facility, Hollister-Stier Laboratories. A pre-approval inspection of that facility is planned for early January, the earliest date that FDA investigators could observe a filling operation.