lunes, 22 de marzo de 2010

How do I report a problem with an FDA-regulated product?

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 Coordinator1 for your geographic region.
Report to FDA’s MedWatch2 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 Online3
Report by Mail: Use postage paid Form FDA 35004
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)5 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 Coordinator6 for your geographic region.
Report complaints online related to FDA-regulated clinical trials7
Report complaints online related to Unlawful Sales of Products on the Internet8.

please see the original document:
http://www.fda.gov/AboutFDA/Basics/ucm194891.htm

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