Drug & Medical Device Complaints – Report to the FDA
Most Consumer Complaints:
Here’s some useful information to have when you want to report a complaint concerning food or drugs. Most consumer complaints related to food and drugs can be reported to the Food and Drug Administration through its MEDWATCH program as follows:
- ONLINE: https: //www.accessdata.fda.gov/scripts/medwatch/ (click consumer)
- VIA U.S. MAIL : Send attached form FDA 3500B to
MedWatch
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857 - FAX: 1-800-332-0178 (toll-free)
- PHONE: 1-800-FDA-1088
Vaccines:
- ONLINE: https://vaers.hhs.gov/esub/step1
- VIA U.S. MAIL: Send VAERS form to
VAERS
P.O. Box 1100
Rockville MD 20849-1100 - FAX: (877) 721-0366
Helpful PDF Files:
Click below to view a PDF copy of the pages from the Food and Drug Administration:
- How To Report an Adverse Event or Serious Problem to FDA
- How to Report a Non Emergency
- FDA form 3500B
- Medwatch Voluntary Report Online
A good agency to report problems with meat or poultry is the U.S. Department of Agriculture. To report call the USDA hotline at 1-800-535-4555.