Adverse Event Reporting

Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act, a manufacturer, packer, or distributor of dietary supplements whose name appears on the label of a dietary must report to the FDA certain adverse events associated with the product and maintain reports of adverse events. EAS Consulting Group assists clients with reporting adverse events as well as developing short and long-term protocols for the remediation of those events. We can train your employees on these new or updated procedures and conduct audits for compliance to policies in the future.