FDA 483 - Bracco Diagnostics, Inc. - November 27, 2024

Bracco Diagnostics, Inc. in Princeton, NJ was inspected from November 20-27, 2024. The inspection revealed significant deficiencies in the firm's adverse drug experience reporting system, including the untimely submission of over 30 serious and unexpected individual case safety reports to the FDA. Additionally, the firm lacked adequate written procedures for post-marketing adverse drug experience reporting, and existing procedures for Periodic Adverse Drug Experience Reports (PADERs) were found to be incorrect or incomplete.