FDA 483 - Bioport Corporation - September 21, 2000

During a September 2000 inspection, Bioport Corporation, a licensed vaccine manufacturer in Lansing, MI, was cited for multiple deficiencies related to vaccine manufacturing and reporting. Observations included inadequate procedures for adverse event reporting, improper vaccine dosing, deficient labeling procedures, and untimely submission of required reports to the FDA. The findings indicate a lack of robust quality system controls for vaccine production and post-market surveillance.