Next Upcoming Seminar: Developing and Implementing SQF Systems – a Training Partnership with HACCP Consulting Group – February 6-7, 2018

Specializing in FDA Regulatory Matters

Adverse Event Reporting

Adverse Event Reporting & Record Keeping: 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.