The Safety Reporting Portal

The Safety Reporting Portal (SRP) streamlines the process of reporting product safety issues to the Food & Drug Administration (FDA) and the National Institutes of Health (NIH).

Whatever your role, (manufacturer, health care professional, researcher, public health official, or concerned citizen), when you submit a safety report through this Portal, you make a vital contribution to the safety of America's food supply, medicines, and other products that touch us all.

Parts of this website have been translated from English to Spanish. Pages that have been translated have an “En Espanol” link in the upper right part of the page. Click this link to see the page in Spanish (Espanol). Click “In English” to see the page in English. In the case of any discrepancy in meaning, the English version is considered official. Currently, report questions are only in English and reports should only be submitted in English. Thank you for using the FDA Safety Reporting Portal.

Who Should Submit a Safety Report?

Organizations and people in certain professional roles, such as the following, may be required by law to submit safety reports under some circumstances.

• Food Manufacturers, Processors, Packers, and Holders
• Researchers
• An applicant of an approved drug product or a manufacturer, distributor or packer listed on the label of any marketed drug product
• Drug Manufacturers
• Sponsors, sponsor-investigators of investigational drugs and biologics
• Dietary supplement manufacturers, packers, and distributors

Others, including healthcare providers, public health officials, and other professionals, as well as consumers and concerned citizens, may voluntarily submit reports if they encounter safety issues with a product and/or unanticipated harmful effects that they believe are related to a product.

Learn more about mandatory and voluntary reporting.