About FDA
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How do I report a problem with an FDA-regulated product?
There are several ways you can report problems to FDA:
- Call the FDA Consumer Complaint Coordinator for your geographic region.
- Report to FDA’s MedWatch program any product problems or unexpected side effects (adverse events) that occur while using drugs, medical devices, dietary supplements, infant formulas, cosmetics, and blood products and other biologics (except for vaccines) either online, by regular mail, by fax, or by phone.
- Report a Serious Medical Product Problem Online
- Report by Mail: Use postage paid Form FDA 3500
- Report by Fax: 1-800-FDA-0178
- Report by Phone: 1-800-332-1088
- Report a vaccine-related illness or injury to the Vaccine Adverse Event Reporting System (VAERS) or call 1-800-822-7967 to request a reporting form.
- Report a problem with animal drugs by calling 1-888-FDA-VETS. To report complaints about pet food (and other animal feed), call the FDA Consumer Complaint Coordinator for your geographic region.
- Report complaints online related to FDA-regulated clinical trials
Report complaints online related to Unlawful Sales of Products on the Internet.
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