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:

  1. ONLINE: https: //www.accessdata.fda.gov/scripts/medwatch/ (click consumer)
  2. VIA U.S. MAIL : Send attached form FDA 3500B to
    Food and Drug Administration
    5600 Fishers Lane
    Rockville, MD 20857
  3. FAX: 1-800-332-0178 (toll-free)
  4. PHONE: 1-800-FDA-1088


  1. ONLINE: https://vaers.hhs.gov/esub/step1
  2. VIA U.S. MAIL: Send VAERS form to
    P.O. Box 1100
    Rockville MD 20849-1100
  3. FAX: (877) 721-0366

Helpful PDF Files:

Click below to view a PDF copy of the pages from the Food and Drug Administration:

  1. How To Report an Adverse Event or Serious Problem to FDA
  2. How to Report a Non Emergency
  3. FDA form 3500B
  4. 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.