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Online Reporting Form: Health Professionals For use by health professionals, consumers, and patients. Instructions for Completing Form FDA 3500. Form FDA 3500 - Voluntary Reporting (pdf)
Online: Use the interactive form at FDA Form 3500. FDA encourages online reporting because it is the quickest and most direct route. Fax: Get the form (as above) and fax to...
To report an emergency involving food, drugs, medical devices, dietary supplements, or cosmetics, call 1-866-300-4374 or 1-301-796-8240. Call 1-888-INFO-FDA (1-888-463-6332). Call the FDA...
USDA’s Food Safety and Inspection Service (FSIS) — Call the toll-free USDA Meat and Poultry Hotline at 888-674-6854 or report the complaint online. It’s important before you call FSIS or...
FDA encourages online reporting because it is the quickest and most direct route. Mail - Download the pre-addressed, postage-paid FDA Form 3500 or call 1-800-FDA-1088 to request the form. Fax - Get the form (as above) and fax it to 1-800-FDA-0178.
For more information on how to report safety issues, please use the following link: "Report a Health or Problem to the FDA". 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.
The FDA’s SmartHub is designed to help the public navigate to the appropriate form or resources to report a problem with an FDA regulated human or animal product (e.g. defects in the quality or safety of a product, or labeling issue), adverse health experience (e.g. injury, illness, or death associated with a product), or facility issue (e.g ...
Report what happened as soon as possible. Give names, addresses, and phone numbers of persons affected. Include your name, address, email, and phone number, as well as that of any doctor or...
If the issue you are reporting is a health problem and/or product problem (defect) involving a tobacco product, please enter the report using the Safety Report Portal. For complaints or...
To report adverse reactions or other problems with FDA-regulated products, contact the FDA Consumer Complaint Coordinator for the state in which you reside.