FDA serious adverse effect reporting

The responsible person is required to report serious adverse events associated with the use of cosmetic products in the United States to the FDA. If the responsible person receives medical or other information regarding a serious adverse event within 1 year of the initial notification to FDA, he or she must submit this new information to FDA within 15 business days. FDA will also have access to reports of serious adverse events during an inspection.

You can contact us via the e-mail address agent@macroprof.us to receive Serious Adverse Effect Reporting service to ensure compliance with your cosmetic products that you market in the USA.