Guide to Reporting Problems to FDA

Do you know how to report problems to FDA? This resource will inform you on how to report problems. 

Below are some tips:

1. Report what happened as soon as possible after you discover a problem. Be prepared to provide the following information:

  • names, addresses, and phone numbers of people affected
  • your name, postal and e-mail address, and phone number
  • name, address, and phone number of the doctor or hospital that provided emergency treatment
  • product codes or identifying marks on the label or container
  • name and address of store where product was bought and date of purchase
  • name and address of company on the product label

2. Do not discard the product packaging and labeling. They provide codes, numbers, and dates that can help FDA trace the product back to the plant that manufactured it.

3. In addition to reporting to FDA, the agency recommends reporting the problem to the manufacturer and to the store where the product was purchased.

4. When in doubt about how to report a problem, call your local FDA Consumer Complaint Coordinator. Consumers can also visit FDA’s Safety Reporting Portal to report a safety issue. To see a full list of products the FDA regulates, along with safety reporting information, visit the safety report directory. Using this portal also streamlines the process of reporting product safety issues to the FDA.

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