FDA 483 - K. W. Griffen Company DBA Biomed Packaging Systems - March 15, 2024

K. W. Griffen Company DBA Biomed Packaging Systems in Norwalk, CT, was cited for multiple failures related to adverse drug experience (ADE) reporting and record-keeping. The inspection revealed a lack of written procedures for ADE surveillance and reporting, along with failures to submit periodic and annual reports and maintain ADE records for the required duration. These issues indicate significant deficiencies in the firm's post-marketing drug surveillance and regulatory compliance.